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DQX

766 FDA 510(k) clearances · Product code

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RecordFirmDate
RADIFOCUS GLIDEWIRE ADVANTAGE (K063372)Terumo Medical Corp.2007-01-19
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J (K062186)Asahi Intecc Co., Ltd.2006-11-09
TREASURE (K061984)Asahi Intecc Co., Ltd.2006-10-05
HI-TORQUE WHISPER VIEW GUIDE WIRE (K061453)Guidant Corp.2006-06-22
BRIVANT GUIDEWIRE (K060551)Brivant Limited2006-06-07
SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX (K061171)Biosphere Medical, Inc.2006-06-02
HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE (K060449)Guidant Corporation2006-05-30
MICRUS GUIDE WIRE, WATUSI 0.014 (K053265)Micrus Endovascular Corporation2006-04-28
AMPLATZER NOODLEWIRE GUIDEWIRE (K053187)Aga Medical Corp.2006-04-27
TITAN GUIDEWIRE (K060454)Lake Region Mfg., Inc.2006-03-24
PVS 2000 SYNCHRO2 GUIDEWIRE (K053268)Boston Scientific - Precision Vascular2006-03-13
TECHDEVICE GUIDEWIRE (K053251)Techdevice Corporation2006-03-08
TITAN STEERABLE (PTCA) GUIDEWIRE (K052347)Lake Region Mfg., Inc.2006-02-17
ASAHI PTCA GUIDE WIRE (K052339)Asahi Intecc Co., Ltd.2005-11-30
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX (K052783)Boston Scientific Corp2005-10-27
ASAHI PTCA GUIDE WIRE FIELDER (K052022)Asahi Intecc Co., Ltd.2005-08-25
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO (K051062)Flowcardia, Inc.2005-07-15
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (K051374)Stereotaxis, Inc.2005-06-23
PV 1900 SYNCHRO 0.016 GUIDEWIRE (K050964)Boston Scientific - Precision Vascular2005-06-13
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] (K050915)Intra Luminal Therapeutics, Inc.2005-06-07
CANALIZER HYDROPHILIC GUIDE WIRE (K050873)Medical Device Technologies, Inc.2005-05-26
SKIPPER AND SKIPPER RACE GUIDEWIRE (K050756)Invatec Innovative Technologies, S.R.L.2005-05-05
GALEO FOCUS GUIDE WIRE (K042373)Biotronik, Inc.2005-03-02
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE (K043398)Neometrics, Inc.2005-03-01
MODIFICATION TO ENDOVASCULAR GUIDE WIRE (K043457)Stereotaxis, Inc.2005-02-28
STEREOTAXIS ENDOVASCULAR GUIDE WIRE (K042854)Stereotaxis, Inc.2005-02-08
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES (K043422)Asahi Intecc Co., Ltd.2005-01-12
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE (K040592)Cordis Corp.2004-12-17
TORAYGUIDE GUIDEWIRE (K042370)Toray Industries (America), Inc.2004-12-17
GUIDEWIRES (K042264)Rocket Medical Plc2004-11-24
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE (K042996)Volcano Therapeutics, Inc.2004-11-24
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE (K042611)Cook, Inc.2004-11-12
SILICONE COATED GUIDEWIRE (K041740)Arrow International, Inc.2004-10-15
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE (K042338)Lake Region Mfg., Inc.2004-09-16
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K041973)Intra Luminal Therapeutics, Inc.2004-08-16
FINISHING WIRE SUPPORTRAK (K041762)Guidant Corporation2004-08-06
ASAHI PTCA GUIDE WIRE CONFIANZA PRO (K041531)Asahi Intecc Co., Ltd.2004-08-03
PTCA STEERABLE HYDROPHILIC GUIDEWIRE (K041624)Lake Region Mfg., Inc.2004-07-16
LAKE REGION HYDROPHILIC GUIDEWIRE (K040825)Lake Region Mfg., Inc.2004-05-17
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315 (K040867)Boston Scientific Corp2004-04-30
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING (K040786)Neometrics, Inc.2004-04-19
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K040037)Intra Luminal Therapeutics, Inc.2004-03-03
MODIFICATION TO NITREX NITINOL GUIDEWIRE (K040345)Ev3, Inc.2004-03-02
ARROW ECHOGENIC INTRODUCER NEEDLE (K040100)Arrow Intl., Inc.2004-03-01
IQ GUIDE WIRE (K040140)Boston Scientific Corp2004-02-12
BOSTON SCIENTIFIC V-18 CONTROL WIRE (K033742)Boston Scientific Corp2004-01-12
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K033929)Intra Luminal Therapeutics, Inc.2004-01-12
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K032031)Intra Luminal Therapeutics, Inc.2004-01-07
HYDROPHILIC GUIDEWIRE (K033758)Lake Region Mfg., Inc.2003-12-19
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K033708)Intra Luminal Therapeutics, Inc.2003-12-11
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE (K033542)Galt Medical Corp.2003-12-05
SELECTIVA SB GUIDEWIRE (K033321)Neometrics, Inc.2003-11-05
RADIUS COUGAR WIRE (K032899)Radius Medical Technologies, Inc.2003-10-17
JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE (K032411)Js Vascular, Inc.2003-10-07
VASCUPUNCTURE PICC GUIDEWIRE (K031652)Neometrics, Inc.2003-09-30
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 (K032615)Asahi Intecc Co., Ltd.2003-09-16
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K031678)Guidant Corp.2003-08-26
PBN GUIDEWIRES (K031442)Medical Device Technologies, Inc.2003-08-13
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES (K032146)Precision Vascular Systems, Inc.2003-08-12
PERIVAC KIT (K032050)Boston Scientific Corp2003-08-08
IQ HYDROPHILIC GUIDE WIRE (K032183)Boston Scientific Corp2003-08-01
RADIUS 018 COUGAR WIRE (K032129)Radius Medical Technologies, Inc.2003-07-17
GALT MEDICAL GUIDEWIRE (K031916)Galt Medical Corp.2003-07-17
NITREX NITINOL GUIDEWIRE (K031864)Ev3 Corporation2003-06-24
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE (K030617)Boston Scientific Scimed, Inc.2003-05-21
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG (K030549)Guidcorp2003-05-14
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 (K031277)Jomed, Inc.2003-05-14
STEERABLE GUIDEWIRE (K022813)Lake Region Mfg., Inc.2003-02-14
NITREX NITINOL GUIDEWIRE (K024021)Ev3 Corporation2003-01-24
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE (K030019)Guidant Corp.2003-01-24
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 (K022762)Jomed, Inc.2002-12-16
PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE (K023700)Precision Vascular Systems, Inc.2002-12-04
ENDOVASCULAR GUIDE WIRE (K021363)Stereotaxis, Inc.2002-11-27
HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J (K023300)Guidant Corp.2002-10-28
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 (K022357)Boston Scientific, Target2002-10-16
ILT ADVANCING MECHANISM, MODEL A115AMI (K021638)Intra Luminal Therapeutics, Inc.2002-07-26
GALT MEDICAL GUIDEWIRE (K021990)Galt Medical Corp.2002-07-18
ILT TORQUER, MODEL 114TR1 (K021243)Intra Luminal Therapeutics, Inc.2002-07-11
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 (K020821)Biotronik, Inc.2002-06-03
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM (K021323)Intra Luminal Therapeutics, Inc.2002-05-22
SMARTWIRE/SMARTMAP PRESSURE SYSTEM (K021219)Jomed, Inc.2002-05-17
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE (K021228)Guidant Corp.2002-05-15
HI-TORQUE EXTRA S'PORT GUIDEWIRE (K021285)Guidant Corp.2002-05-02
SAFE-STEER GUIDE WIRE SYSTEM (K011986)Intra Luminal Therapeutics, Inc.2002-04-03
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 (K014075)Baylis Medical Co., Inc.2002-03-07
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING (K020340)Guidant Corp.2002-03-01
BACK-UP MEIER STEERABLE GUIDEWIRE (K020283)Boston Scientific Corp2002-02-11
VASCUPUNCTURE ACCESS WIRE (K012861)Neometrics, Inc.2002-02-05
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K012534)Advanced Cardiovascular Systems, Inc.2002-01-24
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096 (K013833)Guidant Corp.2002-01-16
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K013092)Guidant Corp.2001-12-13
SELECTIVA GUIDEWIRE (K013024)Neometrics, Inc.2001-12-04
SNIPER ELITE MODEL-OR-E3872XX SERIES (K011905)Maxxim Medical2001-08-28
BACK-UP MEIER GUIDEWIRE (K011906)Boston Scientific Corp2001-08-13
STREERABLE PTCA GUIDEWIRE (K011968)Lake Region Mfg., Inc.2001-07-25
RADIUS COUGAR WIRE (K011287)Radius Medical Technologies, Inc.2001-05-25
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 (K003084)Concentric Medical, Inc.2001-05-16
MANDREL GUIDEWIRE ASSEMBLY (K011084)Lake Region Mfg., Inc.2001-05-10
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300 (K010497)Micro Therapeutics, Inc.2001-03-22
PVS 1300 NEURO GUIDE WIRE (K002907)Precision Vascular Systems, Inc.2001-03-08
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