FDA Product Code
FDA Product Code DQY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 896 records · page 5 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K091841 | BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 | Bridgepoint Medical | 2009-09-02 | Special | PDF ↗ |
| K092299 | TRAILBLAZER SUPPORT CATHETER | Ev3, Inc. | 2009-08-07 | Traditional | PDF ↗ |
| K092075 | CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009-08-07 | Special | PDF ↗ |
| K090918 | NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER | Nfocus Neuromedical, Inc. | 2009-07-30 | Traditional | PDF ↗ |
| K091793 | AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 | Aga Medical Corp. | 2009-07-09 | Special | PDF ↗ |
| K090613 | CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009-07-01 | Special | PDF ↗ |
| K091299 | SPECTRANETICS TURBO-TANDEM SYSTEM | Spectranetics Corp. | 2009-07-01 | Traditional | PDF ↗ |
| K090977 | PIGGYBACK WIRE CONVERTER | Vascular Solutions, Inc. | 2009-06-18 | Traditional | PDF ↗ |
| K091527 | ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER | Cook, Inc. | 2009-06-12 | Special | PDF ↗ |
| K091345 | GOPHER GOLD CATHETER, MODEL 5620 | Vascular Solutions, Inc. | 2009-06-12 | Special | PDF ↗ |
| K091254 | THE CROSSER 14 OTW CATHETER, MODEL CRU014 | Flowcardia, Inc. | 2009-05-29 | Special | PDF ↗ |
| K083833 | ENABLER-P CATHETER, 1000 PART NUMBER:1160 | Endocross, Ltd. | 2009-05-22 | Traditional | PDF ↗ |
| K081130 | BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER | Bridgepoint Medical | 2009-05-14 | Traditional | PDF ↗ |
| K083214 | AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 | Aga Medical Corp. | 2009-05-12 | Special | PDF ↗ |
| K090335 | HD GUIDE CATHETER | Concentric Medical, Inc. | 2009-05-06 | Special | PDF ↗ |
| K090913 | CROSS-PILOT TURBO ELITE SUPPORT CATHETER | Spectranetics Corp. | 2009-05-04 | Traditional | PDF ↗ |
| K090849 | MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 | Ev3, Inc. | 2009-05-01 | Special | PDF ↗ |
| K090822 | ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER | Cook, Inc. | 2009-04-27 | Special | PDF ↗ |
| K090659 | ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY | Medtronic, Inc. | 2009-03-26 | Special | PDF ↗ |
| K090509 | FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER | Abbott Vascular-Vascular Solutions | 2009-03-20 | Special | PDF ↗ |
| K083919 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | Invatec Innovative Technologies, S.R.L. | 2009-03-13 | Traditional | PDF ↗ |
| K083596 | REEKROSS FAMILY OR OTW PTA CATHETERS | ClearStream Technologies , Ltd. | 2009-03-02 | Traditional | PDF ↗ |
| K083422 | 6F TAIGA GUIDING CATHETER | Medtronic Vascular | 2009-02-06 | Special | PDF ↗ |
| K080987 | BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES | Bridgepoint Medical | 2009-02-06 | Traditional | PDF ↗ |
| K083127 | ASAHI CORSAIR MICROCATHETER | Asahi Intecc Co., Ltd. | 2009-02-03 | Traditional | PDF ↗ |
| K083313 | WILDCAT 7F GUIDEWIRE SUPPORT CATHETER | Avinger, Inc. | 2009-02-02 | Traditional | PDF ↗ |
| K081878 | LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM | LeMaitre Vascular, Inc. | 2009-01-27 | Traditional | PDF ↗ |
| K082337 | MINNIE SUPPORT CATHETER | Vascular Solutions, Inc. | 2009-01-15 | Traditional | PDF ↗ |
| K083657 | CONQUEST PTA BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 2008-12-24 | Traditional | PDF ↗ |
| K082932 | CPS AIM SL SLITTABLE INNER CATHETER | St Jude Medical | 2008-12-12 | Special | PDF ↗ |
| K082385 | CHAPERON GUIDING CATHETER | MicroVention, Inc. | 2008-12-11 | Traditional | PDF ↗ |
| K082559 | SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER | Spectranetics Corp. | 2008-12-11 | Traditional | PDF ↗ |
| K082561 | SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS | Spectranetics Corp. | 2008-12-10 | Traditional | PDF ↗ |
| K080428 | ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY | Medtronic, Inc. | 2008-12-09 | Traditional | PDF ↗ |
| K082670 | MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET | Medtronic, Inc. | 2008-12-04 | Special | PDF ↗ |
| K083343 | HEADWAY 17 MICROCATHETER | MicroVention, Inc. | 2008-12-04 | Traditional | PDF ↗ |
| K082854 | NANOCORSS .014 OTW PTA DILATATION CATHETER | Ev3, Inc. | 2008-12-04 | Traditional | PDF ↗ |
| K083139 | VIPERSPHERE PTA BALLOON CATHETER | Cardiovascular Systems, Inc. | 2008-11-25 | Traditional | PDF ↗ |
| K083125 | NEURON SELECT CATHETER SIZE 070 | Penumbra, Inc. | 2008-11-21 | Special | PDF ↗ |
| K082579 | EVERCROSS .035 OTW PTA DILATATION CATHETER | Ev3, Inc. | 2008-11-20 | Traditional | PDF ↗ |
| K082339 | ENABLER-P SUPPORT CATHETER | Endocross, Ltd. | 2008-11-20 | Traditional | PDF ↗ |
| K082933 | PASSEO-35 PTA CATHETER | Biotronik, Inc. | 2008-11-03 | Special | PDF ↗ |
| K082646 | OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER | Usci Ireland | 2008-11-03 | Special | PDF ↗ |
| K082290 | NEURON DELIVERY CATHETER 070 | Penumbra, Inc. | 2008-10-31 | Special | PDF ↗ |
| K082868 | MULLINS-X, MODEL 250X | NuMED, Inc. | 2008-10-24 | Special | PDF ↗ |
| K081799 | GORE TRI-LOBE BALLOON CATHETER | W. L. Gore & Associates, Inc. | 2008-10-03 | Traditional | PDF ↗ |
| K073700 | 6F PROXIS SYSTEM | St. Jude Medical, Inc. | 2008-10-02 | Traditional | PDF ↗ |
| K082524 | MINI GHOST, MODEL: 507 | NuMED, Inc. | 2008-09-26 | Special | PDF ↗ |
| K080849 | MICROSHEATH LP AND LP-AT | Flowcardia, Inc. | 2008-07-25 | Traditional | PDF ↗ |
| K080583 | MODIFIED HD GUIDE CATHETER | Concentric Medical, Inc. | 2008-07-18 | Special | PDF ↗ |
| K081680 | NUCLEUS-X, MODEL 230X | NuMED, Inc. | 2008-07-10 | Special | PDF ↗ |
| K080994 | AMPLATZER TORQVUE EXCHANGE SYSTEM | Aga Medical Corp. | 2008-05-16 | Traditional | PDF ↗ |
| K080988 | SCOUTPRO CS LEAD INTRODUCER SYSTEM | Biotronik, Inc. | 2008-05-07 | Special | PDF ↗ |
| K080757 | AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM | Aga Medical Corp. | 2008-04-18 | Special | PDF ↗ |
| K080360 | ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER | Endologix, Inc. | 2008-04-08 | Special | PDF ↗ |
| K072329 | SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED | Biotronik, Inc. | 2008-03-25 | Special | PDF ↗ |
| K080154 | ACUITY UNIVERSAL CUTTER | Cardiac Pacemakers, Inc. | 2008-03-20 | Special | PDF ↗ |
| K070126 | OCCLUSION BALLOON CATHETER | Sentreheart, Inc. | 2008-02-08 | Traditional | PDF ↗ |
| K073289 | MICROSHEATH XL CATHETERS | Flowcardia, Inc. | 2008-01-11 | Traditional | PDF ↗ |
| K073378 | ADVANCE 18LP PTA DILATATION CATHETER | Cook, Inc. | 2007-12-28 | Special | PDF ↗ |
| K072750 | SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 | Spectranetics Corp. | 2007-12-04 | Special | PDF ↗ |
| K072618 | TWIN-PASS OTW CATHETER, MODEL 5201 | Vascular Solutions, Inc. | 2007-11-21 | Traditional | PDF ↗ |
| K072156 | OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER | Usci Ireland | 2007-11-09 | Traditional | PDF ↗ |
| K072313 | AMPLATZER TORQVUE DELIVERY SYSTEM | Aga Medical Corp. | 2007-11-02 | Traditional | PDF ↗ |
| K070502 | RADIUS SNARE | Radius Medical Technologies, Inc. | 2007-10-04 | Traditional | PDF ↗ |
| K072283 | DORADO PTA BALLOON DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2007-09-19 | Traditional | PDF ↗ |
| K072316 | PRECIOUS PLUS GUIDE CATHETER | Asahi Intecc Co., Ltd. | 2007-09-17 | Special | PDF ↗ |
| K070970 | NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F | Penumbra, Inc. | 2007-08-17 | Traditional | PDF ↗ |
| K071665 | SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 | Biotronik, Inc. | 2007-07-18 | Special | PDF ↗ |
| K062885 | STRIDE MICROCATHETER | Asahi Intecc Co., Ltd. | 2007-06-13 | Traditional | PDF ↗ |
| K070372 | GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610 | Vascular Solutions, Inc. | 2007-06-01 | Traditional | PDF ↗ |
| K063638 | MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 | St Jude Medical | 2007-05-11 | Traditional | PDF ↗ |
| K070051 | ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM | Acumen Medical, Inc. | 2007-04-06 | Traditional | PDF ↗ |
| K070238 | AMPLATZER RELIANT CATHETER DELIVERY SYSTEM | Aga Medical Corp. | 2007-02-28 | Traditional | PDF ↗ |
| K062868 | THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 | Flowcardia, Inc. | 2007-01-19 | Traditional | PDF ↗ |
| K061680 | ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER | Atrium Medical Corp. | 2006-12-15 | Traditional | PDF ↗ |
| K061601 | ASAHI PRECIOUS GUIDE CATHETER | Asahi Intecc Co., Ltd. | 2006-11-17 | Traditional | PDF ↗ |
| K063252 | ATB ADVANCED PTA DILATATION CATHETER | Cook, Inc. | 2006-11-14 | Special | PDF ↗ |
| K061416 | SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 | Medtronic Vascular | 2006-10-25 | Traditional | PDF ↗ |
| K062202 | OCCLUSION BALLOON | Boston Scientific Corp | 2006-10-20 | Special | PDF ↗ |
| K062809 | ADMIRAL XTREME PTA CATHETER | Invatec Innovative Technologies | 2006-10-18 | Special | PDF ↗ |
| K062609 | MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER | AngioDynamics, Inc. | 2006-10-06 | Special | PDF ↗ |
| K060927 | CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES | Ceres Medical Systems, LLC | 2006-10-06 | Traditional | PDF ↗ |
| K062594 | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM | Boston Scientific Corporation | 2006-09-20 | Special | PDF ↗ |
| K062420 | 5F SHERPA ACTIVE NX GUIDE CATHETER | Medtronic Vascular | 2006-09-08 | Special | PDF ↗ |
| K061480 | ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM | Medtronic, Ireland | 2006-08-21 | Traditional | PDF ↗ |
| K062084 | 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 | Acumen Medical, Inc. | 2006-08-18 | Special | PDF ↗ |
| K042850 | CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) | Stereotaxis, Inc. | 2006-08-09 | Traditional | PDF ↗ |
| K061843 | VENTURE WIRE CONTROL CATHETER, MODEL WCC | St Jude Medical | 2006-08-01 | Special | PDF ↗ |
| K061710 | CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS | St Jude Medical | 2006-07-14 | Special | PDF ↗ |
| K060745 | ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY | Asahi Intecc Co., Ltd. | 2006-06-23 | Special | PDF ↗ |
| K061119 | ENPATH MEDICAL STEERABLE SHEATH | Enpath Medical, Inc. | 2006-05-18 | Special | PDF ↗ |
| K053491 | PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F | Penumbra, Inc. | 2006-04-27 | Traditional | PDF ↗ |
| K060807 | SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM | Biotronik, Inc. | 2006-04-24 | Special | PDF ↗ |
| K060327 | VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER | Vascular Solutions, Inc. | 2006-04-12 | Traditional | PDF ↗ |
| K060655 | SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H | Biotronik, Inc. | 2006-04-04 | Special | PDF ↗ |
| K053431 | ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM | Medtronic, Ireland | 2006-03-16 | Traditional | PDF ↗ |
| K060572 | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM | Boston Scientific Corporation | 2006-03-15 | Special | PDF ↗ |
| K060418 | 8F SHERPA NX GUIDE CATHETER | Medtronic Vascular | 2006-03-15 | Special | PDF ↗ |
| K053217 | CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 | St Jude Medical | 2006-03-08 | Traditional | PDF ↗ |
Product code DQY · Class II · Cardiovascular. Data: openFDA.