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 |
|---|---|---|---|
| Jan 14, 2013 | K123311 | QXMEDICAL ACCESS & SUPPORT CATHETER Qxmedical, LLC | DQY |
| Jan 11, 2013 | K123324 | SELECTRA 7F CATHETERS Biotronik, Inc. | DQY |
| Jan 3, 2013 | K123452 | TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM Stryker | DQY |
| Dec 21, 2012 | K121077 | NHANCER Imds Operations B.V., NL | DQY |
| Dec 14, 2012 | K123531 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER LeMaitre Vascular, Inc. | DQY |
| Dec 7, 2012 | K122684 | REVERSE MEDICAL MICROCATHETER Reverse Medical Corporation | DQY |
| Nov 27, 2012 | K121763 | MULTICROSS SUPPORT CATHETER Roxwood Medical, Inc. | DQY |
| Nov 21, 2012 | K122581 | MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 Concentric Medical, Inc. | DQY |
| Nov 20, 2012 | K122772 | PENUMBRA DDC CATHETERS Penumbra, Inc. | DQY |
| Sep 25, 2012 | K121219 | ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER Medtronic, Inc. | DQY |
| Aug 31, 2012 | K121859 | TYSHAK NUCLEUS NuMED, Inc. | DQY |
| Aug 30, 2012 | K122394 | RUBICON 18 SUPPORT CATHETER Boston Scientific Corp | DQY |
| Aug 23, 2012 | K121611 | AMPLATZER TORQVUE FX Aga Medical Corporation | DQY |
| Aug 15, 2012 | K121352 | ARMADA 14XXT PTA CATHETER Abbott Vascular | DQY |
| Aug 9, 2012 | K120781 | CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH Fuji Systems Corp. | DQY |
| Aug 8, 2012 | K121839 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER LeMaitre Vascular, Inc. | DQY |
| Aug 8, 2012 | K120585 | CONVEY GUIDING CATHETER Pendracare International, B.V. | DQY |
| Jun 13, 2012 | K121051 | CONCIERGE GUIDING CATHETER Merit Medical Systems, Inc. | DQY |
| May 25, 2012 | K120964 | UPSTREAM GR CATHETER Upstream Peripheral Technologies | DQY |
| May 15, 2012 | K120707 | SWITCH-IT CATHETER Vascular Solutions, Inc. | DQY |
| May 11, 2012 | K120296 | CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER St. Jude Medical, Cardiac Rhythm Management Divisi | DQY |
| Apr 20, 2012 | K113778 | EXCELSIOR XT-27 MICROCATHETER Stryker Neurovascular | DQY |
| Mar 20, 2012 | K112100 | M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER Vascular Solutions, Inc. | DQY |
| Mar 15, 2012 | K120120 | AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH Aga Medical Corporation | DQY |
| Mar 15, 2012 | K112404 | CONCENTRIC BALLOON GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Feb 24, 2012 | K120381 | Q50 PLUS STENT GRAFT BALLOON CATHETER Qxmedical, LLC | DQY |
| Feb 24, 2012 | K120229 | ENVOY DISTAL ACCESS GUIDING CATHETER Codman & Shurtleff, Inc. | DQY |
| Feb 23, 2012 | K112886 | UPSTREAM SUPPORT CATHETER Upstream Peripheral Technologies | DQY |
| Feb 8, 2012 | K120178 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER Reflow Medical | DQY |
| Feb 3, 2012 | K120129 | MANTARAY CATHETER Bridgepoint Medical | DQY |
| Jan 12, 2012 | K102439 | FUNNEL GUIDE CATHETER MODEL G1020608 Lazarus Effect, Inc. | DQY |
| Jan 5, 2012 | K112035 | VALET MICRO CATHETER Volcano Corporation | DQY |
| Jan 4, 2012 | K113589 | BIGBOSS CATHETER Bridgepoint Medical | DQY |
| Dec 14, 2011 | K111738 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) Trireme Medical, Inc. | DQY |
| Dec 1, 2011 | K112082 | GUIDELINER V2 CATHETER Vascular Solutions, Inc. | DQY |
| Nov 17, 2011 | K113112 | CLEARWAY RX NB CATHETER Atrium Medical Corp. | DQY |
| Nov 9, 2011 | K112303 | RUBICON SUPPORT CATHETER Boston Scientific | DQY |
| Nov 2, 2011 | K112262 | REFLEX BALLON GUIDE CATHETER Reverse Medical Corporation | DQY |
| Oct 27, 2011 | K112917 | ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID Medtronic, Inc. | DQY |
| Oct 25, 2011 | K112828 | REVIVE INTERMEDIATE CATHETER (REVIVE IC) Codman & Shurtleff, Inc. | DQY |
| Oct 17, 2011 | K112032 | 8FR TURBO - TANDEM SYSTEM Spectranetics Corp. | DQY |
| Oct 12, 2011 | K112335 | BANTAM CATHETER (280MM BALLOON LENGTHS) ClearStream Technologies , Ltd., IE | DQY |
| Oct 11, 2011 | K112629 | ONSET ACCESS CATHETER SYSTEM Onset Medical Corporation | DQY |
| Oct 6, 2011 | K112579 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER Avinger, Inc. | DQY |
| Sep 26, 2011 | K112482 | SELECTRA SLITTER TOOL Biotronik, Inc. | DQY |
| Sep 26, 2011 | K111839 | SELECTRA ACCESSORY KIT Biotronik, Inc. | DQY |
| Sep 13, 2011 | K110891 | THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER LeMaitre Vascular, Inc. | DQY |
| Sep 9, 2011 | K111704 | AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX Avinger, Inc. | DQY |
| Aug 17, 2011 | K112281 | GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX Trireme Medical, Inc. | DQY |
| Aug 10, 2011 | K111963 | BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER Bridgepoint Medical | DQY |
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