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

Company	510(k)s	Recalls
Cook Incorporated	26	61
Boston Scientific	34	42
Argon Medical Devices, Inc.	1	53
Asahi Intecc Co., Ltd.	48	0
Advanced Cardiovascular Systems, Inc.	45	0
Arrow International, Inc.	1	31
Lake Region Mfg., Inc.	31	0
Merit Medical Systems, Inc.	22	9
Scimed Life Systems, Inc.	30	0
Guidant Corp.	27	0

Decided	510(k)	Device and applicant	Code
Apr 29, 1998	K980360	SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES Scimed Life Systems, Inc.	DQX
Apr 24, 1998	K980294	ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp.	DQX
Apr 24, 1998	K972793	PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE Radi Medical Systems AB, SE	DQX
Mar 20, 1998	K980119	ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE Guidant Corp.	DQX
Mar 13, 1998	K974773	HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC Guidant Corp.	DQX
Jan 12, 1998	K973945	LUGE GUIDE WIRE Scimed Life Systems, Inc.	DQX
Jan 5, 1998	K973845	CORDIS HYDRONOL STEERABLE GUIDEWIRE Cordis Corp.	DQX
Dec 19, 1997	K973708	TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL Merit Medical Systems, Inc.	DQX
Dec 19, 1997	K971086	RADIAL AND FEMORAL ARTERY CATHETER B.Braun Medical, Inc.	DQX
Dec 12, 1997	K973494	HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG Guidant Corp.	DQX
Dec 11, 1997	K971688	IVT 0.014 PTFE-COATED TRACKWIRE Boston Scientific /International Technologies	DQX
Nov 17, 1997	K970938	HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING Biocompatibles Cardiovascular, Inc.	DQX
Nov 3, 1997	K972944	MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT Medtronics Interventional Vascular	DQX
Nov 3, 1997	K971719	THEROX INFUSION GUIDEWIRES Therox, Inc.	DQX
Oct 14, 1997	K972762	CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES Cardio Metrics, Inc.	DQX
Oct 9, 1997	K971281	RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE Medcomp	DQX
Sep 17, 1997	K972290	ACS HI-TORQUE RULER GUIDE WIRE Guidant Corp.	DQX
Aug 25, 1997	K972142	ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING Guidant Corp.	DQX
Aug 18, 1997	K965140	CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM Cardio Metrics, Inc.	DQX
Jul 14, 1997	K971395	GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE Target Therapeutics	DQX
Jul 9, 1997	K971815	ASC BALANCE MIDDLEWEIGHT GUIDE WIRE Guidant Corp.	DQX
Jul 1, 1997	K971254	TRANSEND EX PLATINUM GUIDEWIRE Boston Scientific Corp	DQX
Jun 10, 1997	K970528	CLYDE CORONARY GUIDEWIRE Schneider (Europe) GmbH, CH	DQX
Jun 6, 1997	K970376	PTCA GUIDEWIRE Lake Region Mfg., Inc.	DQX
May 21, 1997	K964551	CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID Scimed Life Systems, Inc.	DQX
May 20, 1997	K970690	LOCKING STYLET 2 Cook Pacemaker Corp.	DQX
May 9, 1997	K970494	HANNIBAL GUIDEWIRE Schneider (Europe) GmbH, CH	DQX
Mar 28, 1997	K970244	SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES Scimed Life Systems, Inc.	DQX
Mar 4, 1997	K965023	CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE Scimed Life Systems, Inc.	DQX
Feb 21, 1997	K962765	CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS) Cordis Corp.	DQX
Jan 28, 1997	K964611	TRANSEND GUIDEWIRE Boston Scientific Corp	DQX
Jan 28, 1997	K964352	TORQUE DEVICE B.Braun Medical, Inc.	DQX
Jan 22, 1997	K963702	ACS HI-TORQUE IRON MAN GUIDE WIRE Advanced Cardiovascular Systems, Inc.	DQX
Dec 17, 1996	K962572	SCIMED CHOICE PT VISION PTCA GUIDE WIRE Scimed Life Systems, Inc.	DQX
Dec 17, 1996	K954642	HYDRO-SELECT GUIDEWIRE Microvena Corp.	DQX
Dec 3, 1996	K963320	TFX MEDICAL GUIDEWIRE Tfx Medical Group	DQX
Nov 20, 1996	K961917	MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) Medtronics Interventional Vascular	DQX
Nov 13, 1996	K963214	CORDIS ST STEERABLE GUIDEWIRE Cordis Corp.	DQX
Nov 7, 1996	K963171	CINCH QR SGW EXTENSION Cordis Corp.	DQX
Oct 25, 1996	K962932	CORDIS STABILIZER PLUS XS Cordis Corp.	DQX
Oct 1, 1996	K961107	B. BRAUN GUIDEWIRES B.Braun Medical, Inc.	DQX
Sep 10, 1996	K962266	0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING Biocompatibles Cardiovascular, Inc.	DQX
Jul 31, 1996	K961777	ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 Cardio Metrics, Inc.	DQX
Jul 9, 1996	K961445	RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL Terumo Medical Corp.	DQX
Jun 27, 1996	K961271	USCI COMMANDER SERIES GUIDE WIRES C.R. Bard, Inc.	DQX
Jun 26, 1996	K961232	0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP Biocompatibles , Ltd.	DQX
May 23, 1996	K960755	CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS Medtronic Cardiac Surgery, Medtronic, Inc.	DQX
May 21, 1996	K960718	LRM Lake Region Mfg., Inc.	DQX
May 16, 1996	K955304	CRICKET Microvena Corp.	DQX
May 15, 1996	K961015	SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE Scimed Life Systems, Inc.	DQX

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