Panels › Cardiovascular › Product code DQX · Class 2
Wire, Guide, Catheter
Regulation 870.1330
12510(k)s in 12 months (769 all time)
7recalls in 12 months (258 all time)
224recalls that name a 510(k)
Top companies in DQX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 7, 2004 | K032031 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM Intra Luminal Therapeutics, Inc. | DQX |
| Dec 19, 2003 | K033758 | HYDROPHILIC GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Dec 11, 2003 | K033708 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM Intra Luminal Therapeutics, Inc. | DQX |
| Dec 5, 2003 | K033542 | EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE Galt Medical Corp. | DQX |
| Nov 5, 2003 | K033321 | SELECTIVA SB GUIDEWIRE Neometrics, Inc. | DQX |
| Oct 17, 2003 | K032899 | RADIUS COUGAR WIRE Radius Medical Technologies, Inc. | DQX |
| Oct 7, 2003 | K032411 | JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE Js Vascular, Inc. | DQX |
| Sep 30, 2003 | K031652 | VASCUPUNCTURE PICC GUIDEWIRE Neometrics, Inc. | DQX |
| Sep 16, 2003 | K032615 | ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 Asahi Intecc Co., Ltd. | DQX |
| Aug 26, 2003 | K031678 | HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. | DQX |
| Aug 13, 2003 | K031442 | PBN GUIDEWIRES Medical Device Technologies, Inc. | DQX |
| Aug 12, 2003 | K032146 | PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES Precision Vascular Systems, Inc. | DQX |
| Aug 8, 2003 | K032050 | PERIVAC KIT Boston Scientific Corp | DQX |
| Aug 1, 2003 | K032183 | IQ HYDROPHILIC GUIDE WIRE Boston Scientific Corp | DQX |
| Jul 17, 2003 | K032129 | RADIUS 018 COUGAR WIRE Radius Medical Technologies, Inc. | DQX |
| Jul 17, 2003 | K031916 | GALT MEDICAL GUIDEWIRE Galt Medical Corp. | DQX |
| Jun 24, 2003 | K031864 | NITREX NITINOL GUIDEWIRE Ev3 Corporation | DQX |
| May 21, 2003 | K030617 | PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE Boston Scientific Scimed, Inc. | DQX |
| May 14, 2003 | K031277 | JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 Jomed, Inc. | DQX |
| May 14, 2003 | K030549 | HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG Guidcorp | DQX |
| Feb 14, 2003 | K022813 | STEERABLE GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| Jan 24, 2003 | K030019 | MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE Guidant Corp. | DQX |
| Jan 24, 2003 | K024021 | NITREX NITINOL GUIDEWIRE Ev3 Corporation | DQX |
| Dec 16, 2002 | K022762 | JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 Jomed, Inc. | DQX |
| Dec 4, 2002 | K023700 | PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE Precision Vascular Systems, Inc. | DQX |
| Nov 27, 2002 | K021363 | ENDOVASCULAR GUIDE WIRE Stereotaxis, Inc. | DQX |
| Oct 28, 2002 | K023300 | HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J Guidant Corp. | DQX |
| Oct 16, 2002 | K022357 | TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 Boston Scientific, Target | DQX |
| Jul 26, 2002 | K021638 | ILT ADVANCING MECHANISM, MODEL A115AMI Intra Luminal Therapeutics, Inc. | DQX |
| Jul 18, 2002 | K021990 | GALT MEDICAL GUIDEWIRE Galt Medical Corp. | DQX |
| Jul 11, 2002 | K021243 | ILT TORQUER, MODEL 114TR1 Intra Luminal Therapeutics, Inc. | DQX |
| Jun 3, 2002 | K020821 | SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 Biotronik, Inc. | DQX |
| May 22, 2002 | K021323 | MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM Intra Luminal Therapeutics, Inc. | DQX |
| May 17, 2002 | K021219 | SMARTWIRE/SMARTMAP PRESSURE SYSTEM Jomed, Inc. | DQX |
| May 15, 2002 | K021228 | HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE Guidant Corp. | DQX |
| May 2, 2002 | K021285 | HI-TORQUE EXTRA S'PORT GUIDEWIRE Guidant Corp. | DQX |
| Apr 3, 2002 | K011986 | SAFE-STEER GUIDE WIRE SYSTEM Intra Luminal Therapeutics, Inc. | DQX |
| Mar 7, 2002 | K014075 | BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 Baylis Medical Co., Inc., CA | DQX |
| Mar 1, 2002 | K020340 | MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. | DQX |
| Feb 11, 2002 | K020283 | BACK-UP MEIER STEERABLE GUIDEWIRE Boston Scientific Corp | DQX |
| Feb 5, 2002 | K012861 | VASCUPUNCTURE ACCESS WIRE Neometrics, Inc. | DQX |
| Jan 24, 2002 | K012534 | HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Advanced Cardiovascular Systems, Inc. | DQX |
| Jan 16, 2002 | K013833 | HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096 Guidant Corp. | DQX |
| Dec 13, 2001 | K013092 | HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. | DQX |
| Dec 4, 2001 | K013024 | SELECTIVA GUIDEWIRE Neometrics, Inc. | DQX |
| Aug 28, 2001 | K011905 | SNIPER ELITE MODEL-OR-E3872XX SERIES Maxxim Medical | DQX |
| Aug 13, 2001 | K011906 | BACK-UP MEIER GUIDEWIRE Boston Scientific Corp | DQX |
| Jul 25, 2001 | K011968 | STREERABLE PTCA GUIDEWIRE Lake Region Mfg., Inc. | DQX |
| May 25, 2001 | K011287 | RADIUS COUGAR WIRE Radius Medical Technologies, Inc. | DQX |
| May 16, 2001 | K003084 | CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 Concentric Medical, Inc. | DQX |
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