Volcano Corporation
Rancho Cordova, CA, US
VOLCANO CORPORATION appears in FDA device records in Rancho Cordova, CA. FDA records list 55 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 36 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 55FDA records hold 55 510(k) clearances for Volcano Corporation between 2005 and 2021. The busiest year on record is 2015, with 10. The most recent is 2021, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 5 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 4 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 4 |
| 2013 | 8 |
| 2014 | 3 |
| 2015 | 10 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210235 | Verrata PLUS Pressure Guide Wire | DQX | Substantially Equivalent | |
| K203719 | IntraSight Mobile | IYO | Substantially Equivalent | |
| K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | DQX | Substantially Equivalent | |
| K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | DQX | Substantially Equivalent | |
| K190626 | SyncVision System | OWB | Substantially Equivalent | |
| K190078 | IntraSight | DSA | Substantially Equivalent | |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System | IYO | Substantially Equivalent | |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit | IYO | Substantially Equivalent | |
| K172574 | SyncVision System | OWB | Substantially Equivalent | |
| K170385 | CORE M2 Vascular System | IYO | Substantially Equivalent | |
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | OBJ | Substantially Equivalent | |
| K161887 | Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip | DQX | Substantially Equivalent | |
| K161756 | SyncVision System | OWB | Substantially Equivalent | |
| K153094 | Visions PV .035 Digital IVUS Catheter | OBJ | Substantially Equivalent | |
| K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz | IYO | Substantially Equivalent | |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box | DSK | Substantially Equivalent | |
| K152829 | Visions PV.014P RX Digital IVUS Catheter | OBJ | Substantially Equivalent | |
| K150442 | Volcano Visions PV .018 Digital IVUS Catheter | OBJ | Substantially Equivalent | |
| K143701 | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM | OBJ | Substantially Equivalent | |
| K151904 | SyncVision System | OWB | Substantially Equivalent | |
| K150262 | Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular | DTK | Substantially Equivalent | |
| K150441 | Volcano iFR Modality, iFR Scout feature | IYO | Substantially Equivalent | |
| K143122 | Volcano iFR Harvest Software (Offline) | IYO | Substantially Equivalent | |
| K133323 | VOLCANO IFR MODALITY | IYO | Substantially Equivalent | |
| K140291 | VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS | IYO | Substantially Equivalent | |
| K133681 | CRUX SNARE FILTER RETRIEVAL SET | MMX | Substantially Equivalent | |
| K133641 | CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE | IYO | Substantially Equivalent | |
| K132558 | SYNC-RX SYSTEM | OWB | Substantially Equivalent | |
| K133142 | VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION | IYO | Substantially Equivalent | |
| K132659 | VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM | DQY | Substantially Equivalent | |
| K131288 | VERRATA PRESSURE GUIDE WIRE | DQX | Substantially Equivalent | |
| K123482 | REFLOW ASPIRATION CATHETER | QEZ | Substantially Equivalent | |
| K122826 | PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM | DQY | Substantially Equivalent | |
| K123898 | VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM | IYO | Substantially Equivalent | |
| K121273 | VISIONS PV .035 DITITAL IVUS CATHETER | OBJ | Substantially Equivalent | |
| K120697 | EAGLE EYE PLATINUM ST CATHETER | OBJ | Substantially Equivalent | |
| K113486 | VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM | IYO | Substantially Equivalent | |
| K112035 | VALET MICRO CATHETER | DQY | Substantially Equivalent | |
| K111395 | PRIMEWIRE PRESTIGE PLUS | DQX | Substantially Equivalent | |
| K111706 | VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM | IYO | Substantially Equivalent | |
| K100930 | PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J | DQX | Substantially Equivalent | |
| K092596 | EAGLE EYE PLATINUM DIGITAL IVUS CATHETER | OBJ | Substantially Equivalent | |
| K082229 | S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM | IYO | Substantially Equivalent | |
| K080891 | REVOLUTION 45MHZ IVUS IMAGING CATHETER | OBJ | Substantially Equivalent | |
| K073473 | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 | OBJ | Substantially Equivalent | |
| K071554 | VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM | OBJ | Substantially Equivalent | |
| K071660 | VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 | OBJ | Substantially Equivalent | |
| K070487 | SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX | DXO | Substantially Equivalent | |
| K061215 | VOLCANO S51 FAMILY OF IMAGING SYSTEMS | IYO | Substantially Equivalent | |
| K060483 | VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM | IYO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2939520 | 2939520 | VOLCANO CORPORATION | 2451 Mercantile Drive, Rancho Cordova, CA 95742 US | 2026 | and 1 more, listed in full below |
| 3008363989 | 3008363989 | Volcano Corporation | 3721 Valley Centre Dr Ste 500, San Diego, CA 92130 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- QEZAspiration Thrombectomy Catheter
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- CATCannula, Nasal, Oxygen
- PDUCatheter For Crossing Total Occlusions
- DQYCatheter, Percutaneous
- MCWCatheter, Peripheral, Atherectomy
- OBJCatheter, Ultrasound, Intravascular
- DSKComputer, Blood-Pressure
- DQKComputer, Diagnostic, Programmable
- BZAConnector, Airway (Extension)
- DSIDetector And Alarm, Arrhythmia
- MMXDevice, Percutaneous Retrieval
- KKXDrape, Surgical, Antimicrobial
- DTKFilter, Intravascular, Cardiovascular
- OWBInterventional Fluoroscopic X-Ray System
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXOTransducer, Pressure, Catheter Tip
- ITXTransducer, Ultrasonic, Diagnostic
- CBKVentilator, Continuous, Facility Use
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 36| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2221-2025 | Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use. | Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire" | Class II | Open, Classified | |
| Z-1270-2022 | Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 | Due to a potential failed sterilization process. | Class II | Terminated | |
| Z-1302-2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797 | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Class III | Open, Classified | |
| Z-1301-2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797 | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Class III | Open, Classified | |
| Z-0917-2022 | MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems | Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets. | Class III | Open, Classified | |
| Z-0901-2022 | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information. | Class III | Open, Classified | |
| Z-0885-2022 | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x | If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives. | Class II | Open, Classified | |
| Z-0674-2020 | Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R. | Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS). | Class II | Terminated | |
| Z-0727-2019 | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices. | Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter. | Class II | Terminated | |
| Z-0726-2019 | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices. | Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter. | Class II | Terminated | |
| Z-1891-2018 | Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. | The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image. | Class II | Terminated | |
| Z-0189-2018 | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished REF 400-0100.08-R; CORE Imaging System REF 400-0100.02 For intravascular ultrasound imaging. | On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device. | Class II | Terminated | |
| Z-1776-2017 | Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. | High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging. | Class II | Terminated | |
| Z-1775-2017 | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. | High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging. | Class II | Terminated | |
| Z-1813-2016 | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. | Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot | Class II | Terminated | |
| Z-1042-2016 | Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them. | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date. | Class II | Terminated | |
| Z-1041-2016 | Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them. | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date. | Class II | Terminated | |
| Z-2718-2015 | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. | Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters. | Class II | Terminated | |
| Z-2136-2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | Class II | Terminated | |
| Z-2135-2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | Class II | Terminated | |
| Z-2134-2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | Class II | Terminated | |
| Z-2133-2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | Class II | Terminated | |
| Z-2132-2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | Class II | Terminated | |
| Z-2131-2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | Class II | Terminated | |
| Z-1845-2015 | Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease. | During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture | Class II | Terminated |
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