| NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER (K090918) | Nfocus Neuromedical, Inc. | 2009-07-30 |
| AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 (K091793) | Aga Medical Corp. | 2009-07-09 |
| SPECTRANETICS TURBO-TANDEM SYSTEM (K091299) | Spectranetics Corp. | 2009-07-01 |
| CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 (K090613) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009-07-01 |
| PIGGYBACK WIRE CONVERTER (K090977) | Vascular Solutions, Inc. | 2009-06-18 |
| ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K091527) | Cook, Inc. | 2009-06-12 |
| GOPHER GOLD CATHETER, MODEL 5620 (K091345) | Vascular Solutions, Inc. | 2009-06-12 |
| THE CROSSER 14 OTW CATHETER, MODEL CRU014 (K091254) | Flowcardia, Inc. | 2009-05-29 |
| ENABLER-P CATHETER, 1000 PART NUMBER:1160 (K083833) | Endocross, Ltd. | 2009-05-22 |
| BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER (K081130) | Bridgepoint Medical | 2009-05-14 |
| AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 (K083214) | Aga Medical Corp. | 2009-05-12 |
| HD GUIDE CATHETER (K090335) | Concentric Medical, Inc. | 2009-05-06 |
| CROSS-PILOT TURBO ELITE SUPPORT CATHETER (K090913) | Spectranetics Corp. | 2009-05-04 |
| MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 (K090849) | Ev3, Inc. | 2009-05-01 |
| ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER (K090822) | Cook, Inc. | 2009-04-27 |
| ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY (K090659) | Medtronic, Inc. | 2009-03-26 |
| FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER (K090509) | Abbott Vascular-Vascular Solutions | 2009-03-20 |
| AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K083919) | Invatec Innovative Technologies, S.R.L. | 2009-03-13 |
| REEKROSS FAMILY OR OTW PTA CATHETERS (K083596) | ClearStream Technologies , Ltd. | 2009-03-02 |
| BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES (K080987) | Bridgepoint Medical | 2009-02-06 |
| 6F TAIGA GUIDING CATHETER (K083422) | Medtronic Vascular | 2009-02-06 |
| ASAHI CORSAIR MICROCATHETER (K083127) | Asahi Intecc Co., Ltd. | 2009-02-03 |
| WILDCAT 7F GUIDEWIRE SUPPORT CATHETER (K083313) | Avinger, Inc. | 2009-02-02 |
| LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM (K081878) | LeMaitre Vascular, Inc. | 2009-01-27 |
| MINNIE SUPPORT CATHETER (K082337) | Vascular Solutions, Inc. | 2009-01-15 |
| CONQUEST PTA BALLOON DILATATION CATHETER (K083657) | C.R. Bard, Inc. | 2008-12-24 |
| CPS AIM SL SLITTABLE INNER CATHETER (K082932) | St Jude Medical | 2008-12-12 |
| CHAPERON GUIDING CATHETER (K082385) | MicroVention, Inc. | 2008-12-11 |
| SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER (K082559) | Spectranetics Corp. | 2008-12-11 |
| SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS (K082561) | Spectranetics Corp. | 2008-12-10 |
| ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY (K080428) | Medtronic, Inc. | 2008-12-09 |
| MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET (K082670) | Medtronic, Inc. | 2008-12-04 |
| NANOCORSS .014 OTW PTA DILATATION CATHETER (K082854) | Ev3, Inc. | 2008-12-04 |
| HEADWAY 17 MICROCATHETER (K083343) | MicroVention, Inc. | 2008-12-04 |
| VIPERSPHERE PTA BALLOON CATHETER (K083139) | Cardiovascular Systems, Inc. | 2008-11-25 |
| NEURON SELECT CATHETER SIZE 070 (K083125) | Penumbra, Inc. | 2008-11-21 |
| EVERCROSS .035 OTW PTA DILATATION CATHETER (K082579) | Ev3, Inc. | 2008-11-20 |
| ENABLER-P SUPPORT CATHETER (K082339) | Endocross, Ltd. | 2008-11-20 |
| OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER (K082646) | Usci Ireland | 2008-11-03 |
| PASSEO-35 PTA CATHETER (K082933) | Biotronik, Inc. | 2008-11-03 |
| NEURON DELIVERY CATHETER 070 (K082290) | Penumbra, Inc. | 2008-10-31 |
| MULLINS-X, MODEL 250X (K082868) | NuMED, Inc. | 2008-10-24 |
| GORE TRI-LOBE BALLOON CATHETER (K081799) | W. L. Gore & Associates, Inc. | 2008-10-03 |
| 6F PROXIS SYSTEM (K073700) | St. Jude Medical, Inc. | 2008-10-02 |
| MINI GHOST, MODEL: 507 (K082524) | NuMED, Inc. | 2008-09-26 |
| MICROSHEATH LP AND LP-AT (K080849) | Flowcardia, Inc. | 2008-07-25 |
| MODIFIED HD GUIDE CATHETER (K080583) | Concentric Medical, Inc. | 2008-07-18 |
| NUCLEUS-X, MODEL 230X (K081680) | NuMED, Inc. | 2008-07-10 |
| AMPLATZER TORQVUE EXCHANGE SYSTEM (K080994) | Aga Medical Corp. | 2008-05-16 |
| SCOUTPRO CS LEAD INTRODUCER SYSTEM (K080988) | Biotronik, Inc. | 2008-05-07 |
| AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM (K080757) | Aga Medical Corp. | 2008-04-18 |
| ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER (K080360) | Endologix, Inc. | 2008-04-08 |
| SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED (K072329) | Biotronik, Inc. | 2008-03-25 |
| ACUITY UNIVERSAL CUTTER (K080154) | Cardiac Pacemakers, Inc. | 2008-03-20 |
| OCCLUSION BALLOON CATHETER (K070126) | Sentreheart, Inc. | 2008-02-08 |
| MICROSHEATH XL CATHETERS (K073289) | Flowcardia, Inc. | 2008-01-11 |
| ADVANCE 18LP PTA DILATATION CATHETER (K073378) | Cook, Inc. | 2007-12-28 |
| SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 (K072750) | Spectranetics Corp. | 2007-12-04 |
| TWIN-PASS OTW CATHETER, MODEL 5201 (K072618) | Vascular Solutions, Inc. | 2007-11-21 |
| OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER (K072156) | Usci Ireland | 2007-11-09 |
| AMPLATZER TORQVUE DELIVERY SYSTEM (K072313) | Aga Medical Corp. | 2007-11-02 |
| RADIUS SNARE (K070502) | Radius Medical Technologies, Inc. | 2007-10-04 |
| DORADO PTA BALLOON DILATATION CATHETER (K072283) | Bard Peripheral Vascular, Inc. | 2007-09-19 |
| PRECIOUS PLUS GUIDE CATHETER (K072316) | Asahi Intecc Co., Ltd. | 2007-09-17 |
| NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F (K070970) | Penumbra, Inc. | 2007-08-17 |
| SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 (K071665) | Biotronik, Inc. | 2007-07-18 |
| STRIDE MICROCATHETER (K062885) | Asahi Intecc Co., Ltd. | 2007-06-13 |
| GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610 (K070372) | Vascular Solutions, Inc. | 2007-06-01 |
| MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 (K063638) | St Jude Medical | 2007-05-11 |
| ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM (K070051) | Acumen Medical, Inc. | 2007-04-06 |
| AMPLATZER RELIANT CATHETER DELIVERY SYSTEM (K070238) | Aga Medical Corp. | 2007-02-28 |
| THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 (K062868) | Flowcardia, Inc. | 2007-01-19 |
| ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER (K061680) | Atrium Medical Corp. | 2006-12-15 |
| ASAHI PRECIOUS GUIDE CATHETER (K061601) | Asahi Intecc Co., Ltd. | 2006-11-17 |
| ATB ADVANCED PTA DILATATION CATHETER (K063252) | Cook, Inc. | 2006-11-14 |
| SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 (K061416) | Medtronic Vascular | 2006-10-25 |
| OCCLUSION BALLOON (K062202) | Boston Scientific Corp | 2006-10-20 |
| ADMIRAL XTREME PTA CATHETER (K062809) | Invatec Innovative Technologies | 2006-10-18 |
| MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER (K062609) | AngioDynamics, Inc. | 2006-10-06 |
| CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES (K060927) | Ceres Medical Systems, LLC | 2006-10-06 |
| MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM (K062594) | Boston Scientific Corporation | 2006-09-20 |
| 5F SHERPA ACTIVE NX GUIDE CATHETER (K062420) | Medtronic Vascular | 2006-09-08 |
| ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (K061480) | Medtronic, Ireland | 2006-08-21 |
| 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 (K062084) | Acumen Medical, Inc. | 2006-08-18 |
| CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) (K042850) | Stereotaxis, Inc. | 2006-08-09 |
| VENTURE WIRE CONTROL CATHETER, MODEL WCC (K061843) | St Jude Medical | 2006-08-01 |
| CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS (K061710) | St Jude Medical | 2006-07-14 |
| ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY (K060745) | Asahi Intecc Co., Ltd. | 2006-06-23 |
| ENPATH MEDICAL STEERABLE SHEATH (K061119) | Enpath Medical, Inc. | 2006-05-18 |
| PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F (K053491) | Penumbra, Inc. | 2006-04-27 |
| SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM (K060807) | Biotronik, Inc. | 2006-04-24 |
| VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER (K060327) | Vascular Solutions, Inc. | 2006-04-12 |
| SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H (K060655) | Biotronik, Inc. | 2006-04-04 |
| ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM (K053431) | Medtronic, Ireland | 2006-03-16 |
| 8F SHERPA NX GUIDE CATHETER (K060418) | Medtronic Vascular | 2006-03-15 |
| MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM (K060572) | Boston Scientific Corporation | 2006-03-15 |
| CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 (K053217) | St Jude Medical | 2006-03-08 |
| CPS DIRECT SL OUTER CATHETER (K053277) | St Jude Medical | 2006-02-24 |
| VASCON NEUROPATH GUIDING CATHETER (K052004) | Vascon, LLC | 2006-01-19 |
| STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX (K053118) | Boston Scientific Corp | 2005-12-16 |