Panels › Cardiovascular › Product code DQY · Class 2
Catheter, Percutaneous
Regulation 870.1250
13510(k)s in 12 months (896 all time)
2recalls in 12 months (620 all time)
583recalls that name a 510(k)
Top companies in DQY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 31 | 198 |
| Medtronic | 15 | 148 |
| Boston Scientific | 30 | 59 |
| ARROW INTERNATIONAL, LLC | 0 | 41 |
| Stryker Neurovascular | 6 | 30 |
| Cook Incorporated | 22 | 13 |
| Vascular Solutions, Inc. | 27 | 6 |
| Codman & Shurtleff, Inc. | 8 | 24 |
| Bard Peripheral Vascular, Inc. | 5 | 23 |
| Cordis Corp. | 22 | 4 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 1, 2017 | K162467 | Twin-Pass Torque Vascular Solutions, Inc. | DQY |
| Jan 6, 2017 | K162253 | Trapper Exchange Device Creganna Medical Aslo Business AS Cregganna Tactx Medical, IE | DQY |
| Jan 5, 2017 | K162563 | YOGA Microcatheter Codman & Shurtleff, Inc. | DQY |
| Dec 23, 2016 | K163000 | AMPLATZER TorqVue 45x45 Delivery Sheath Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | DQY |
| Nov 2, 2016 | K160561 | Boosting Catheter Qxmedical, LLC | DQY |
| Oct 14, 2016 | K161546 | R2P SlenGuide Ashitaka Factory of Terumo Corporation, JP | DQY |
| Oct 12, 2016 | K161152 | Navien Intracranial Support Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY |
| Sep 22, 2016 | K162384 | TrailBlazer Angled Support Catheter Medtronic Vascular, Inc.(Formerly Ev3 Inc.) | DQY |
| Sep 21, 2016 | K162359 | Surefire Guiding Catheter Surefire Medical, Inc. | DQY |
| Sep 19, 2016 | K161262 | Super Distal Access (SDA) Inneuroco, Inc. | DQY |
| Sep 9, 2016 | K162228 | TorqVue Low Profile Delivery Catheter Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor | DQY |
| Aug 25, 2016 | K161126 | ASAHI Corsair Pro Asahi Intecc Co., Ltd., JP | DQY |
| Aug 4, 2016 | K161986 | SIDEKICK and USHER Support Catheters Bard Peripheral Vascular, Inc. | DQY |
| Jul 14, 2016 | K160848 | Wingman 18 Crossing Catheter Reflow Medical, Inc. | DQY |
| Jul 12, 2016 | K160448 | ARTLINE Health Line International Corporation | DQY |
| Jun 17, 2016 | K160681 | CenterCross Ultra Catheter Roxwood Medical, Inc. | DQY |
| Jun 14, 2016 | K161362 | ASAHI Corsair Armet Asahi Intecc Co., Ltd., JP | DQY |
| May 12, 2016 | K153703 | Guiding Catheter Texasmedical Technologies, Inc. | DQY |
| Mar 11, 2016 | K160389 | NovaCross Microcatheter Nitiloop , Ltd., IL | DQY |
| Mar 4, 2016 | K152957 | MultiCross Catheter Roxwood Medical, Inc. | DQY |
| Mar 4, 2016 | K152249 | ASAHI Corsair Armet Asahi Intecc Co., Ltd., JP | DQY |
| Jan 27, 2016 | K153729 | 8F FlowGate2 Balloon Guide Catheter Concentric Medical | DQY |
| Jan 26, 2016 | K152456 | CenterCross Ultra Catheter Roxwood Medical, Inc. | DQY |
| Jan 22, 2016 | K152447 | ASAHI Caravel Asahi Intecc Co., Ltd., JP | DQY |
| Jan 8, 2016 | K152876 | LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM Tni Manufacturing, Inc. | DQY |
| Dec 14, 2015 | K152202 | Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm Tni Manufacturing, Inc. | DQY |
| Dec 9, 2015 | K151396 | MIVI Mi-AXUS Guide Catheter Mivi Neuroscience, Inc. | DQY |
| Dec 7, 2015 | K151896 | Houdini Catheter Cruzar Medsystems, Inc. | DQY |
| Dec 4, 2015 | K152401 | Stingray LP Catheter Boston Scientific Corporation | DQY |
| Dec 2, 2015 | K152840 | Lantern Delivery Microcatheter Penumbra, Inc. | DQY |
| Nov 13, 2015 | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Stryker | DQY |
| Nov 13, 2015 | K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter Cathera, Inc. | DQY |
| Oct 23, 2015 | K151821 | ER-REBOA Catheter Pryor Medical Devices, Inc. | DQY |
| Aug 28, 2015 | K150894 | VIA 21 Microcatheter Sequent Medical, Inc. | DQY |
| Aug 13, 2015 | K151981 | Turnpike catheter Vascular Solution, Inc. | DQY |
| Aug 7, 2015 | K151880 | Wingman Crossing Catheter Reflow Medical | DQY |
| Aug 7, 2015 | K151409 | Selectra Catheters and Selectra Accessory Kit Biotronik, Inc. | DQY |
| Aug 3, 2015 | K150865 | Metacross RX PTA Balloon Dilitation Catheter KANEKA Corporation, JP | DQY |
| Jul 29, 2015 | K150107 | Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter Micro Therapeutics Inc Dba Ev3 Neurovascular | DQY |
| Jun 23, 2015 | K151103 | ASAHI Corsair Microcatheter Asahi Intecc Co., Ltd., JP | DQY |
| Jun 7, 2015 | K151082 | MicroCross Catheter Roxwood Medical, Inc. | DQY |
| May 12, 2015 | K150970 | Coda LP Balloon Catheter Cook Incorporated | DQY |
| May 4, 2015 | K143608 | NovaCross Microcatheter Nitiloop , Ltd., IL | DQY |
| Apr 14, 2015 | K143744 | MicroCross Catheter Roxwood Medical, Inc. | DQY |
| Apr 1, 2015 | K143459 | Silk Road Acccess Catheter Silk Road Medical, Inc. | DQY |
| Mar 27, 2015 | K150366 | SOFIA 6F Catheter MicroVention, Inc. | DQY |
| Mar 26, 2015 | K142449 | Headway 27 Microcatheter MicroVention, Inc. | DQY |
| Mar 9, 2015 | K141981 | ASAHI FUBUKI 043 / ASAHI FUBUKI Asahi Intecc Co., Ltd. | DQY |
| Feb 27, 2015 | K150201 | Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter Spectranetics, Inc. | DQY |
| Jan 30, 2015 | K141354 | NAVAJO PTA BALLOON DILATATION CATHETER Curative Medical, Inc. | DQY |
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