Company ยท US
Concentric Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2018. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQY | Catheter, Percutaneous | 24 |
| NRY | Catheter, Thrombus Retriever | 18 |
| DQO | Catheter, Intravascular, Diagnostic | 6 |
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | 2 |
| DQX | Wire, Guide, Catheter | 1 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 |
| QEZ | Aspiration Thrombectomy Catheter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 15, 2018 | K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) Concentric Medical, Inc. | POL |
| Sep 2, 2016 | DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Ret Concentric Medical, Inc. | POL |
| Jan 27, 2016 | K153729 | 8F FlowGate2 Balloon Guide Catheter Concentric Medical | DQY |
| Jun 12, 2015 | K150616 | Trevo XP ProVue Retriever (4x30mm) Concentric Medical, Inc. | NRY |
| Apr 6, 2015 | K143077 | Trevo XP ProVue Retriever (6X25mm) Concentric Medical, Inc. | NRY |
| Feb 25, 2014 | K133177 | MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Jan 17, 2014 | K133464 | MODIFIED TREVO PROVUE RETRIEVER Concentric Medical, Inc. | NRY |
| Jan 13, 2014 | K132641 | MODIFIED TREVO PROVUE RETRIEVER Concentric Medical, Inc. | NRY |
| Oct 11, 2013 | K131437 | MODIFIED CONCENTRIC MICROCATHETER Concentric Medical, Inc. | DQO |
| Oct 3, 2013 | K131492 | MODIFIED FLOWGATE BALLOON GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Nov 21, 2012 | K122581 | MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 Concentric Medical, Inc. | DQY |
| Oct 31, 2012 | K122478 | MODIFIED TREVO RETRIEVER Concentric Medical, Inc. | NRY |
| Aug 3, 2012 | K120961 | TREVO RETRIEVER Concentric Medical, Inc. | NRY |
| Mar 15, 2012 | K112404 | CONCENTRIC BALLOON GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Mar 9, 2012 | K113260 | MODIFIED CONCENTIRC MICROCATHETER Concentric Medical, Inc. | DQO |
| Jul 6, 2011 | K111619 | MODIFIED CONCENTRIC MICROCATHETER Concentric Medical, Inc. | DQO |
| Apr 4, 2011 | K110483 | MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Feb 17, 2011 | K093610 | MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 Concentric Medical, Inc. | NRY |
| Nov 17, 2010 | K102657 | CONCENTRIC BALLOON GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Nov 5, 2009 | K092298 | MODIFICATION TO MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Oct 14, 2009 | K091703 | HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 Concentric Medical, Inc. | QEZ |
| Jul 30, 2009 | K091961 | MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 Concentric Medical, Inc. | DQO |
| May 6, 2009 | K090335 | HD GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Feb 12, 2009 | K090085 | MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 Concentric Medical, Inc. | NRY |
| Aug 15, 2008 | K082034 | MODIFICATION TO MERCI RETRIEVER Concentric Medical, Inc. | NRY |
| Jul 18, 2008 | K080583 | MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Jun 5, 2008 | K081305 | MERCI RETRIEVER Concentric Medical, Inc. | NRY |
| Dec 18, 2007 | K072796 | MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 Concentric Medical, Inc. | DQO |
| Aug 22, 2007 | K071172 | MODIFIED MERCI RETRIEVER, MODEL 90060 Concentric Medical, Inc. | NRY |
| Apr 24, 2007 | K070521 | MODIFIED MERCY RETRIEVER, MODEL 90070 Concentric Medical, Inc. | NRY |
| Jan 24, 2007 | K063774 | MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 Concentric Medical, Inc. | NRY |
| Jan 19, 2007 | K062046 | MODIFIED MERCI RETRIEVER, MODEL 90050 Concentric Medical, Inc. | NRY |
| May 25, 2006 | K061059 | MODIFIED MERCI RETRIEVER, MODEL 90092 Concentric Medical, Inc. | NRY |
| Sep 1, 2005 | K051838 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 Concentric Medical, Inc. | DQY |
| May 6, 2005 | K050470 | CONCENTRIC EMBOLIC PEARLS Concentric Medical, Inc. | KRD |
| Aug 11, 2004 | K040745 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 Concentric Medical, Inc. | DQY |
| Aug 11, 2004 | K033736 | MERCI RETRIEVER, MODELS 90065, 90066 Concentric Medical, Inc. | NRY |
| Jun 21, 2004 | K040700 | CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 Concentric Medical, Inc. | DQY |
| Mar 11, 2003 | K030476 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 Concentric Medical, Inc. | DQY |
| Jul 10, 2002 | K021899 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 Concentric Medical, Inc. | DQY |
| Oct 9, 2001 | K010954 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 Concentric Medical, Inc. | DQY |
| May 22, 2001 | K003410 | CONCENTRIC RETRIEVER, MODEL 90030 Concentric Medical, Inc. | DQY |
| May 16, 2001 | K003880 | CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) Concentric Medical, Inc. | DQY |
| May 16, 2001 | K003086 | CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 Concentric Medical, Inc. | DQO |
| May 16, 2001 | K003084 | CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 Concentric Medical, Inc. | DQX |
| Mar 7, 2001 | K003085 | CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 Concentric Medical, Inc. | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2015 | Concentric Medical Inc 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 occlus Terminated |
DQY | K133177 |
| Dec 12, 2014 | Concentric Medical Inc 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 cathete Terminated |
DQY | K110483 |
| Dec 8, 2014 | Concentric Medical Inc 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
i Terminated |
NRY | K120961 |
| Sep 8, 2014 | Concentric Medical Inc 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 fo Terminated |
NRY | K082034 |
| Jan 8, 2013 | Concentric Medical Inc FlowGate Balloon Guide Catheter;
Manufactured by Concentric Medical, Mountain View, CA.
FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinfor Terminated |
DQY | K122581 |
| Jan 12, 2011 | Concentric Medical Inc 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 th Terminated |
GBS | K021899 |
| Jul 20, 2004 | Concentric Medical Inc Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037 Terminated |
DQY | K030476 |
| Jul 20, 2004 | Concentric Medical Inc Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035 Terminated |
DQY | K003410 K030476 |