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 26, 2015 | K142321 | Benchmark Intracranial Access System Penumbra, Inc. | DQY |
| Jan 14, 2015 | K143412 | ADROIT Guiding Catheter Cordis Corporation | DQY |
| Dec 18, 2014 | K142239 | CPS Direct MediGuide Enabled outer catheter St Jude Medical | DQY |
| Dec 18, 2014 | K142235 | CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter St Jude Medical | DQY |
| Dec 3, 2014 | K141529 | ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S | DQY |
| Nov 25, 2014 | K142065 | TURNPIKE CATHETER Vascular Solutions, Inc. | DQY |
| Nov 19, 2014 | K140910 | CENTERCROSS CATHETER Roxwood Medical, Inc. | DQY |
| Nov 14, 2014 | K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior X Stryker Neurovascular | DQY |
| Nov 5, 2014 | K141649 | SPEX SUPPORT CATHETER Reflow Medical | DQY |
| Oct 10, 2014 | K142014 | SOFIA DISTAL ACCESS CATHETER MicroVention, Inc. | DQY |
| Sep 30, 2014 | K141547 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER Reflow Medical | DQY |
| Sep 18, 2014 | K140557 | MIVI 6F GUIDE CATHETER Mivi, LLC | DQY |
| Apr 24, 2014 | K140080 | ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB Codman & Shurtleff, Inc. | DQY |
| Apr 21, 2014 | K140307 | ENVOY GUIDING CATHETER Codman & Shurtleff, Inc. | DQY |
| Apr 3, 2014 | K132914 | ACUITY PRO LEAD DELIVERY SYSTEM Boston Scientific | DQY |
| Mar 26, 2014 | K133539 | TOTAL ACROSS Medtronic Vascular | DQY |
| Feb 26, 2014 | K140034 | SUREFIRE GUIDING CATHETER Surefire Medical, Inc. | DQY |
| Feb 25, 2014 | K133501 | LEADLINER CS LEAD DELIVERY SYSTEM Vascular Solutions, Inc. | DQY |
| Feb 25, 2014 | K133177 | MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Jan 31, 2014 | K131592 | ENLIGHTN RENAL GUIDE CATHETER St. Jude Medical, Inc. | DQY |
| Jan 29, 2014 | K131204 | ADVANCE CS CORONARY SINUS INFUSION CATHETER Cook, Inc. | DQY |
| Dec 31, 2013 | K133026 | UNBALLOON NON-OCCLUSION MODELING CATHETER LeMaitre Vascular, Inc. | DQY |
| Dec 20, 2013 | K132652 | VIA MICROCATHETER, VIA PLUS MICROCATHETER Sequent Medical, Inc. | DQY |
| Nov 22, 2013 | K131482 | SOFIA DISTAL ACCESS CATHETER MicroVention, Inc. | DQY |
| Nov 15, 2013 | K132542 | TRANSGATE GUIDE CATHETER Stryker Neurovascular | DQY |
| Nov 1, 2013 | K130649 | SILK ROAD ACCESS CATHETER Silk Road Medical, Inc. | DQY |
| Oct 24, 2013 | K132556 | SHEATHLESS EAUCATH CORONARY GUIDE CATHETER Asahi Intecc Co., Ltd. | DQY |
| Oct 22, 2013 | K132673 | 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER Medtronic, Inc. | DQY |
| Oct 17, 2013 | K130378 | RESPIGUIDE DELIVERY SYSTEM Respicardia | DQY |
| Oct 11, 2013 | K130858 | REVERSE MEDICAL MICROCATHETER Reverse Medical Corporation | DQY |
| Oct 3, 2013 | K131492 | MODIFIED FLOWGATE BALLOON GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Oct 3, 2013 | K130525 | OCCLUSION PERFUSION CATHETER Advanced Catheter Therapies, Inc. | DQY |
| Sep 27, 2013 | K132659 | VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM Volcano Corporation | DQY |
| Sep 26, 2013 | K132701 | PRIMI SUPPORT CATHETER Thermopeutix, Inc. | DQY |
| Sep 19, 2013 | K132420 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER Reflow Medical | DQY |
| Aug 29, 2013 | K132409 | CONCIERGE GUIDING CATHETER Merit Medical Systems, Inc. | DQY |
| Aug 23, 2013 | K131978 | SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL Biotronik, Inc. | DQY |
| Aug 22, 2013 | K130714 | PROGIGY SUPPORT CATHETER Radius Medical, LLC | DQY |
| Aug 15, 2013 | K131063 | AMPLATZER TORQ VUE LP DELIVERY SYSTEM St Jude Medical | DQY |
| Aug 12, 2013 | K132197 | CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER Pendracare International, B.V. | DQY |
| Aug 2, 2013 | K131493 | SIDEKICK AND USHER SUPPORT CATHETERS C.R. Bard, Inc. | DQY |
| Jun 28, 2013 | K122917 | CODA BALLOON CATHETER Cook, Inc. | DQY |
| Jun 25, 2013 | K130850 | PRIMI AND SECONDI SUPPORT CATHETERS Thermopeutix, Inc. | DQY |
| May 29, 2013 | K131225 | ADROIT GUIDING CATHETER Cordis Corp., A Johnson & Johnson Co. | DQY |
| Apr 24, 2013 | K122826 | PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM Volcano Corporation | DQY |
| Apr 9, 2013 | K123153 | ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT Medtronic, Ireland, IE | DQY |
| Mar 20, 2013 | K130257 | CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER St Jude Medical | DQY |
| Mar 20, 2013 | K130252 | CPS AIM UNIVERSAL SLITTABLE INNER CATHETER St Jude Medical | DQY |
| Mar 19, 2013 | K123765 | GUIDEZILLA GUIDE EXTENSION CATHETER Boston Scientific | DQY |
| Mar 19, 2013 | K122940 | ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 Cook, Inc. | DQY |
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