Concentric Medical, Inc.
Mountain View, CA, US
Concentric Medical, Inc. appears in FDA device records in Mountain View, CA. FDA records list 46 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 8 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 46 510(k) clearances for Concentric Medical, Inc. between 2001 and 2018. The busiest year on record is 2001, with 6. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 6 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 5 |
| 2008 | 3 |
| 2009 | 5 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 5 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 2 |
| 2016 | 2 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) | POL | Substantially Equivalent | |
| DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm | POL | Unknown | |
| K153729 | 8F FlowGate2 Balloon Guide Catheter | DQY | Substantially Equivalent | |
| K150616 | Trevo XP ProVue Retriever (4x30mm) | NRY | Substantially Equivalent | |
| K143077 | Trevo XP ProVue Retriever (6X25mm) | NRY | Substantially Equivalent | |
| K133177 | MODIFIED HD GUIDE CATHETER | DQY | Substantially Equivalent | |
| K133464 | MODIFIED TREVO PROVUE RETRIEVER | NRY | Substantially Equivalent | |
| K132641 | MODIFIED TREVO PROVUE RETRIEVER | NRY | Substantially Equivalent | |
| K131437 | MODIFIED CONCENTRIC MICROCATHETER | DQO | Substantially Equivalent | |
| K131492 | MODIFIED FLOWGATE BALLOON GUIDE CATHETER | DQY | Substantially Equivalent | |
| K122581 | MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 | DQY | Substantially Equivalent | |
| K122478 | MODIFIED TREVO RETRIEVER | NRY | Substantially Equivalent | |
| K120961 | TREVO RETRIEVER | NRY | Substantially Equivalent | |
| K112404 | CONCENTRIC BALLOON GUIDE CATHETER | DQY | Substantially Equivalent | |
| K113260 | MODIFIED CONCENTIRC MICROCATHETER | DQO | Substantially Equivalent | |
| K111619 | MODIFIED CONCENTRIC MICROCATHETER | DQO | Substantially Equivalent | |
| K110483 | MODIFIED HD GUIDE CATHETER | DQY | Substantially Equivalent | |
| K093610 | MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 | NRY | Substantially Equivalent | |
| K102657 | CONCENTRIC BALLOON GUIDE CATHETER | DQY | Substantially Equivalent | |
| K092298 | MODIFICATION TO MODIFIED HD GUIDE CATHETER | DQY | Substantially Equivalent | |
| K091703 | HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 | QEZ | Substantially Equivalent | |
| K091961 | MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 | DQO | Substantially Equivalent | |
| K090335 | HD GUIDE CATHETER | DQY | Substantially Equivalent | |
| K090085 | MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 | NRY | Substantially Equivalent | |
| K082034 | MODIFICATION TO MERCI RETRIEVER | NRY | Substantially Equivalent | |
| K080583 | MODIFIED HD GUIDE CATHETER | DQY | Substantially Equivalent | |
| K081305 | MERCI RETRIEVER | NRY | Substantially Equivalent | |
| K072796 | MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 | DQO | Substantially Equivalent | |
| K071172 | MODIFIED MERCI RETRIEVER, MODEL 90060 | NRY | Substantially Equivalent | |
| K070521 | MODIFIED MERCY RETRIEVER, MODEL 90070 | NRY | Substantially Equivalent | |
| K063774 | MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 | NRY | Substantially Equivalent | |
| K062046 | MODIFIED MERCI RETRIEVER, MODEL 90050 | NRY | Substantially Equivalent | |
| K061059 | MODIFIED MERCI RETRIEVER, MODEL 90092 | NRY | Substantially Equivalent | |
| K051838 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 | DQY | Substantially Equivalent | |
| K050470 | CONCENTRIC EMBOLIC PEARLS | KRD | Substantially Equivalent | |
| K040745 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 | DQY | Substantially Equivalent | |
| K033736 | MERCI RETRIEVER, MODELS 90065, 90066 | NRY | Substantially Equivalent | |
| K040700 | CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 | DQY | Substantially Equivalent | |
| K030476 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 | DQY | Substantially Equivalent | |
| K021899 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 | DQY | Substantially Equivalent | |
| K010954 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 | DQY | Substantially Equivalent | |
| K003410 | CONCENTRIC RETRIEVER, MODEL 90030 | DQY | Substantially Equivalent | |
| K003880 | CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) | DQY | Substantially Equivalent | |
| K003086 | CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 | DQO | Substantially Equivalent | |
| K003084 | CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 | DQX | Substantially Equivalent | |
| K003085 | CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 | DQY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0116-2016 | Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems. | One Distal Access Catheter intended for distribution in Korea, was found at a US location. | Class II | Terminated | |
| Z-2598-2014 | Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature. | Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date. | Class II | Terminated | |
| Z-0528-2015 | Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. | Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications. | Class II | Terminated | |
| Z-0525-2015 | Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. | Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US. | Class II | Terminated | |
| Z-0655-2013 | FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices. | Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration. | Class II | Terminated | |
| Z-0899-2011 | Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty. | Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing. | Terminated | ||
| Z-0086-04 | Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037 | The device has the potential for tip breakage during use. | Terminated | ||
| Z-0085-04 | Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035 | The device has the potential for tip breakage during use. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain