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 |
|---|---|---|---|
| Jun 12, 2015 | K142598 | Opto Wire and OptoMonitor System Opsens, Inc., CA | DQX |
| Jun 11, 2015 | K151244 | Pre-Formed Guidewire Lake Region Medical | DQX |
| May 28, 2015 | K150802 | Heavy Double Flexible Tipped Wire Guide Cook Incorporated | DQX |
| Apr 23, 2015 | K143252 | Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) Needle Tech Products, Inc. | DQX |
| Mar 11, 2015 | K143316 | Attain Hybrid Guide Wire Medtronic, Inc. | DQX |
| Feb 20, 2015 | K143135 | Spring Coil Guidewire Neometrics, Inc. | DQX |
| Jan 21, 2015 | K141707 | ULTRASKIN HYDROPHILIC GUIDE WIRE Lepu Medical Technology (Beijing) Co., Ltd. | DQX |
| Jan 15, 2015 | K143587 | ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire Boston Scientific Corporation | DQX |
| Dec 19, 2014 | K142415 | Hi-Torque JET Guide Wire Family Abbott Vascular, Inc. | DQX |
| Dec 18, 2014 | K141218 | ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM Vadiswire Corporation | DQX |
| Dec 17, 2014 | K142051 | PRELUDE PLASTIC JACKETED GUIDE WIRE Merit Medical Systems, Inc., IE | DQX |
| Dec 17, 2014 | K140536 | HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE Lake Region Medical, IE | DQX |
| Dec 16, 2014 | K141295 | MERIT HYDROPHILIC GUIDEWIRE Merit Medical Systems, Inc., IE | DQX |
| Dec 10, 2014 | K141054 | DISTAL ACCESS TORQUE DEVICE Distal Access, LLC | DQX |
| Nov 25, 2014 | K142393 | PREDICATE III GUIDEWIRE Lake Region Medical | DQX |
| Nov 13, 2014 | K142254 | CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector St Jude Medical | DQX |
| Oct 23, 2014 | K141339 | ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE Asahi Intecc Co., Ltd. | DQX |
| Sep 12, 2014 | K140608 | MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE Merit Medical Systems, Inc., IE | DQX |
| Sep 4, 2014 | K141831 | HYDRAVIEW GUIDEWIRE Brivant Limited, IE | DQX |
| Aug 7, 2014 | K141782 | HI-TORQUE VERSATURN GUIDE WIRE Abbott Vascular | DQX |
| Jun 12, 2014 | K140695 | COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE Medtronic, Inc. | DQX |
| Apr 16, 2014 | K140673 | INSERTION TOOL Boston Scientific Corp | DQX |
| Apr 7, 2014 | K133155 | HYDROPHILIC COATED GUIDEWIRE Lake Region Medical | DQX |
| Mar 27, 2014 | K140485 | MANDREL GUIDEWIRE Lake Region Medical | DQX |
| Mar 18, 2014 | K133865 | ASAHI GAIA FIRST, SECOND, THIRD Asahi Intecc Co., Ltd. | DQX |
| Feb 6, 2014 | K133396 | VDRIVE WITH V-SONO Stereotaxis, Inc. | DQX |
| Dec 19, 2013 | K132623 | MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE Medtronic | DQX |
| Dec 12, 2013 | K133230 | INQWIRE DIAGNOSTIC GUIDE WIRE Merit Medical Systems, Inc., IE | DQX |
| Nov 8, 2013 | K132545 | MEDIVALVE ACWIRE Medivalve , Ltd. | DQX |
| Aug 30, 2013 | K123792 | HORIZON XVU (FFR) Mennen Medical , Ltd., IL | DQX |
| Aug 23, 2013 | K130798 | PRE-FORMED GUIDEWIRES Lake Region Medical, Inc. | DQX |
| Jul 29, 2013 | K131710 | MERIT HYDROPHILIC GUIDE WIRE Merit Medical Systems, Inc., IE | DQX |
| Jul 26, 2013 | K122659 | VDRIVE W/V-SONO Stereotaxis, Inc. | DQX |
| Jul 17, 2013 | K130766 | ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE Cook, Inc. | DQX |
| Jun 21, 2013 | K131288 | VERRATA PRESSURE GUIDE WIRE Volcano Corporation | DQX |
| Jun 13, 2013 | K130104 | GUIDEWIRE, PURSUER SERIES Oscor, Inc. | DQX |
| Apr 5, 2013 | K130588 | MERIT HYDROPHILIC GUIDE WIRE Merit Medical Systems, Inc., IE | DQX |
| Mar 8, 2013 | K122469 | ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ Asahi Intecc Co., Ltd. | DQX |
| Mar 8, 2013 | K122468 | ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO Asahi Intecc Co., Ltd. | DQX |
| Mar 7, 2013 | K124007 | SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY Micro Therapeutics, Inc. D/B/A: Ev3, Inc. | DQX |
| Mar 1, 2013 | K122590 | RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE Terumo Medical Corporation | DQX |
| Feb 28, 2013 | K123707 | ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE Cook, Inc. | DQX |
| Jan 29, 2013 | K123067 | PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY Abbott Vascular, Inc. | DQX |
| Jan 16, 2013 | K123609 | MERIT HYDROPHILIC GUIDE WIRE Merit Medical Systems, Inc. | DQX |
| Dec 13, 2012 | K121398 | CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) Guidepath Medical, Inc. | DQX |
| Nov 20, 2012 | K122573 | HI-TORQUE COMMAND GUIDE WIRE FAMILY Abbott Vascular, Inc. | DQX |
| Nov 8, 2012 | K122795 | STINGRAY GUIDEWIRES Bridgepoint Medical | DQX |
| Oct 26, 2012 | K123024 | TORQUE DEVICE Boston Scientific Corporation | DQX |
| Oct 17, 2012 | K122856 | CHARTER GUIDEWIRE Brivant, Ltd., IE | DQX |
| Sep 21, 2012 | K122089 | OSTIAL PRO STENT POSITIONING SYSTEM Merit Medical Systems, Inc. | DQX |
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