ClearanceBrief
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)
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Top companies in DQX

Decided510(k)Device and applicantCode
Feb 16, 2010K0935153 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON
Brivant, Ltd., IE
DQX
Jan 28, 2010K093822DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY
Shepherd Scientific, Inc.
DQX
Jan 26, 2010K093681MERIDIAN GUIDEWIRE
Ev3 Neurovascular
DQX
Dec 17, 2009K093397TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
MicroVention, Inc.
DQX
Dec 4, 2009K091582GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
Medtronic Vascular
DQX
Oct 27, 2009K092303MERIT LAUREATE HYDROPHILIC GUIDE WIRE
Merit Medical Systems, Inc.
DQX
Sep 25, 2009K091825HI-TORQUE PROGRESS GUIDE WIRE FAMILY
Abbott Vascular, Inc.
DQX
Sep 25, 2009K090193CONDUCTOR CORONARY GUIDEWIRE
Concert Medical, LLC
DQX
Aug 7, 2009K091385APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
Cook, Inc.
DQX
Jul 7, 2009K083094STREAMER POLYMER GUIDEWIRE
Brivant, Ltd., IE
DQX
Jul 2, 2009K090554ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
Boston Scientific Corp
DQX
Mar 25, 2009K081775THE MEDCOMP .010 VASCULAR GUIDEWIRES
Medcomp
DQX
Mar 11, 2009K083738HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05
Abbott Vascular
DQX
Mar 3, 2009K090274MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
Micrus Endovascular Corporation
DQX
Feb 25, 2009K083732TAD AND TAD II TAPERED GUIDE WIRES
Abbott Vascular
DQX
Feb 23, 2009K083713.035 LOC GUIDE WIRE EXTENSION
Abbott Vascular
DQX
Feb 20, 2009K083727STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012
Bridgepoint Medical
DQX
Feb 6, 2009K083706HI-TORQUE VERSACORE GUIDE WIRE
Abbott Vascular
DQX
Feb 6, 2009K082873MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
Medtronic Vascular
DQX
Jan 29, 2009K083904ASAHI SUOH PTCA GUIDE WIRE
Asahi Intecc Co., Ltd.
DQX
Jan 12, 2009K083145ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
Asahi Intecc Co., Ltd.
DQX
Dec 17, 2008K082094BARD PTFE (TEFLON) COATED GUIDE WIRES
C.R. Bard Inc., Bard Electrophysiology Division
DQX
Dec 9, 2008K082922FREEWAY AND RAILRUNNER GUIDEWIRES
Lake Region Mfg., Inc.
DQX
Dec 4, 2008K082935VISION WIRE CORONARY GUIDEWIRE
Biotronik, Inc.
DQX
Nov 21, 2008K083146ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
Asahi Intecc Co., Ltd.
DQX
Oct 8, 2008K081187BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001
Bridgepoint Medical
DQX
Aug 27, 2008K082304ROLL-X GUIDEWIRE
St Jude Medical
DQX
Aug 12, 2008K080637POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
Stereotaxis, Inc.
DQX
Aug 11, 2008K080364FINDRWIRZ GUIDE WIRE SYSTEM
Sentreheart, Inc.
DQX
Aug 8, 2008K081337APPROACH CTO WIRE GUIDE
Cook Incorporated
DQX
Aug 8, 2008K081021KINETIX GUIDEWIRE, PLUS GUIDEWIRE
Boston Scientific Corp
DQX
Jun 20, 2008K080765CROSSER LP SYSTEM
Flowcardia, Inc.
DQX
Apr 17, 2008K080863TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
MicroVention, Inc.
DQX
Apr 11, 2008K072460HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
Abbott Vascular, Inc.
DQX
Mar 20, 2008K080563RUNTHROUGH NS EXTENSION WIRE
Terumo Medical Corp.
DQX
Feb 26, 2008K080144MANDREL GUIDEWIRES OR M-WIRES
Lake Region Mfg., Inc.
DQX
Feb 8, 2008K073162SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING
Kensey Nash Corporation
DQX
Jan 28, 2008K073655PEGASUS STEERABLE (PTCA) GUIDEWIRE
Lake Region Mfg., Inc.
DQX
Jan 9, 2008K073082CPS COURIER GUIDEWIRE
Brivant, Ltd., IE
DQX
Jan 9, 2008K070945ASAHI PTCA GUIDE WIRE
Asahi Intecc Co., Ltd.
DQX
Dec 14, 2007K072552MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
Merit Medical Systems, Inc.
DQX
Oct 23, 2007K072705ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J
Asahi Intecc Co., Ltd.
DQX
Oct 12, 2007K070212CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)
Ovalum , Ltd., IL
DQX
Sep 26, 2007K072431ASAHI PTCA GUIDE WIRE, X-TREME
Asahi Intecc Co., Ltd.
DQX
Aug 24, 2007K071029CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
Stereotaxis, Inc.
DQX
Jul 13, 2007K071721ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
Asahi Intecc Co., Ltd.
DQX
May 24, 2007K062192OSTIAL PRO STENT POSITIONING SYSTEM
Ostial Solutions, LLC
DQX
Apr 27, 2007K070410COOK MICROWIRE WIRE GUIDE
Cook, Inc.
DQX
Apr 27, 2007K063695RUNTHROUGH NS
Terumo Medical Corp.
DQX
Mar 15, 2007K063210ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488
Medtronic Inc. Cardiac Rhythm Management
DQX

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