Baylis Medical Co., Inc.
Mississauga, CA
Baylis Medical Co., Inc. appears in FDA device records in Mississauga, CA. FDA records list 53 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 9 recalls for this company.
FDA records held for this company
510(k) clearance history
Showing 50 of 53FDA records hold 53 510(k) clearances for Baylis Medical Co., Inc. between 1998 and 2025. The busiest year on record is 2019, with 7. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 5 |
| 2003 | 3 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 2 |
| 2015 | 4 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 7 |
| 2020 | 1 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251325 | VersaCross Connect™ Transseptal Dilator | DRE | Substantially Equivalent | |
| K242076 | VersaCross™ RF Wire | DXF | Substantially Equivalent | |
| K241720 | VersaCross Connect™ Transseptal Dilator | DRE | Substantially Equivalent | |
| K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | DYB | Substantially Equivalent | |
| K233647 | VersaCross Connect™ Transseptal Dilator | DRE | Substantially Equivalent | |
| K213898 | ProTrack Pigtail Wire | DQX | Substantially Equivalent | |
| K221351 | Mechanical Guidewire | DQX | Substantially Equivalent | |
| K213582 | Epicardial Access System | DYB | Substantially Equivalent | |
| K220414 | VersaCross Connect Transseptal Dilator | DYB | Substantially Equivalent | |
| K201288 | ExpanSure Large Access Transseptal Dilator | DRE | Substantially Equivalent | |
| K191546 | Epicardial Access System | DYB | Substantially Equivalent | |
| K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable | DRF | Substantially Equivalent | |
| K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | DRF | Substantially Equivalent | |
| K183655 | VersaCross Transseptal Sheath | DYB | Substantially Equivalent | |
| K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | DYB | Substantially Equivalent | |
| K182064 | ExpanSure Transseptal Dilation System | DRE | Substantially Equivalent | |
| K181864 | Polaris RF Ablation System | GXD | Substantially Equivalent | |
| K161949 | OsteoCool V-3 RF Ablation System | GEI | Substantially Equivalent | |
| K161878 | PORTAGE System | HRX | Substantially Equivalent | |
| K152057 | OsteoCool V-3 RF Ablation System | GEI | Substantially Equivalent | |
| K151009 | Nexus Suture | GAT | Substantially Equivalent | |
| K150709 | ProTrack RF Anchor Wire | DXF | Substantially Equivalent | |
| K142480 | OsteoCool V-2 RF Ablation System | GEI | Substantially Equivalent | |
| K132374 | BAYLIS MEDICAL RF PERFORATION PROBE V2.0 | GEI | Substantially Equivalent | |
| K122926 | SUREFLEX STEERABLE GUIDING SHEATH KIT | DYB | Substantially Equivalent | |
| K122278 | BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR | GEI | Substantially Equivalent | |
| K111523 | OSTEOCOOL (TM) RF ABLATION SYSTEM | GEI | Substantially Equivalent | |
| K102948 | TORFLEX TRANSSEPTAL GUIDING SHEATH | DYB | Substantially Equivalent | |
| K102192 | INDISCAL DIGITAL MANOMETER | FMF | Substantially Equivalent | |
| K101372 | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 | GXI | Substantially Equivalent | |
| K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE | PDU | Substantially Equivalent | |
| K101117 | LEV-OR DILATION CATHETER OTW | DQY | Substantially Equivalent | |
| K092877 | INDISCAL ASPIRATION DEVICE AND ACCESSORIES | HRX | Substantially Equivalent | |
| K092337 | PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS | GXI | Substantially Equivalent | |
| K073326 | NRG TRANSSEPTAL NEEDLE | DXF | Substantially Equivalent | |
| K072478 | BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD | GEI | Substantially Equivalent | |
| K071745 | BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE | GXI | Substantially Equivalent | |
| K062937 | TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU | GXI | Substantially Equivalent | |
| K051670 | RF TUNNELER WIRE | PDU | Substantially Equivalent | |
| K053082 | BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 | GXI | Substantially Equivalent | |
| K031949 | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | DXF | Substantially Equivalent | |
| K031951 | TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 | GEI | Substantially Equivalent | |
| K031950 | BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD | GEI | Substantially Equivalent | |
| K023334 | BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 | DSA | Substantially Equivalent | |
| K020354 | BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) | GXD | Substantially Equivalent | |
| K014075 | BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 | DQX | Substantially Equivalent | |
| K013919 | TORFLEX TRANSSEPTAL GUIDING SHEATH | DBY | Substantially Equivalent | |
| K013904 | BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230 | GEI | Substantially Equivalent | |
| K002565 | BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) | GXD | Substantially Equivalent | |
| K010265 | BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HRXArthroscope
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- PDUCatheter For Crossing Total Occlusions
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DQYCatheter, Percutaneous
- DXFCatheter, Septostomy
- DREDilator, Vessel, For Percutaneous Catheterization
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DBYFab, Rhodamine, Antigen, Antiserum, Control
- GXDGenerator, Lesion, Radiofrequency
- DYBIntroducer, Catheter
- GXIProbe, Radiofrequency Lesion
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- FMFSyringe, Piston
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2070-2020 | NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N. | There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection. | Class II | Terminated | |
| Z-2069-2020 | TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90. | There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection. | Class II | Terminated | |
| Z-0393-2017 | NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch. Used to create an atrial septal defect in the heart. | The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle. | Class II | Terminated | |
| Z-0356-2016 | ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular. | Microcatheter may have circumferential defects (cracks) along its shaft. | Class II | Terminated | |
| Z-1442-2015 | ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. | Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft. | Class II | Terminated | |
| Z-0085-2014 | Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations. | The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream. | Class I | Terminated | |
| Z-0879-2013 | BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain. | A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages | Class II | Terminated | |
| Z-1755-2010 | The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4 The LumbarCool Pain Management System, a cooled radiofrequency pain management system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for use to create RF lesions in nervous tissue. | Name of the device reflected on the product packing sleeve is incorrect. | Terminated | ||
| Z-0816-2010 | Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire. Intended to allow left heart catheterization procedure to occur through the right atrium. | Radiopaque soft tip may fracture. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain