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DQX

766 FDA 510(k) clearances · Product code

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RecordFirmDate
Fixed Core Wire Guides (K171764)Cook Incorporated2018-03-09
Warrior 14 guidewire (K180128)Vascular Solutions, Inc.2018-02-16
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter (K171933)Asahi Intecc Co., Ltd.2018-02-12
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile (K173235)Scientia Vascular, LLC2018-01-22
HI-TORQUE TurnTrac Guide Wire Family (K173795)Abbott Vascular2018-01-12
Amplatz Support Wire Guide with Apex Curve (K171445)Cook Incorporated2018-01-10
Roadrunner Extra Support Wire Guide (K171948)Cook Incorporated2018-01-05
Raider Guidewire (K173532)Vascular Solutions, Inc.2017-12-15
Lunderquist Extra Stiff Wire Guide (K171513)William Cook Europe Aps2017-12-07
TXM Hydrophilic Guidewire (K170915)Texasmedical Technologies, Inc.2017-11-21
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled (K173423)Nano4imaging GmbH2017-11-17
WATCHDOG Hemostasis Valve Kit (K172453)Boston Scientific Corporation2017-11-09
Heraeus TMW Guidewire (K173052)Heraeus Medical Components, LLC2017-10-20
Glidewire GT (K170417)Terumo Corporation2017-09-15
Hi-Torque Command 18 Guide Wire (K172073)Abbott Vascular2017-08-25
Approach CTO Microwire Guide (K171897)Cook Incorporated2017-08-21
True Form Reshapable Guide Wire (K170532)Merit Medical Systems, Inc.2017-07-21
Firebow Wire Torque Assist Device (K170684)Vesatek, LLC2017-06-29
Merit Hydrophilic Guide Wire (K170933)Merit Medical Systems, Inc.2017-06-22
Inqwire Diagnostic Guide Wire (K170700)Merit Medical Systems, Inc.2017-04-06
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (K163426)Asahi Intecc Co., Ltd.2017-04-03
Fathom-16 Steerable Guidewires (K170636)Boston Scientific Corporation2017-03-22
Inqwire Diagnostic Guide Wire (K163575)Merit Medical Systems, Inc.2017-03-03
Radifocus Glidewire Advantage Track (K163004)Ashitaka Factory of Terumo Coporation2017-01-30
ASAHI PTCA Guide Wire ASAHI SUOH 03 (K162842)Asahi Intecc Co., Ltd.2017-01-27
Spectre guidewire (K163444)Vascular Solutions, Inc.2017-01-06
Worker Guidewire (K160785)Argon Medical Devices, Inc.2016-12-08
Endura guidewire (K161702)Vascular Solutions, Inc.2016-12-06
MRWire Guide Wire (K160594)Nano4imaging GmbH2016-11-22
ENROUTE 0.014 Guidewire (K160643)Lake Region Medical2016-10-18
Sunmed Haemostatic Valves (K153685)Sunny Medical Device (Shenzhen) Co., Ltd.2016-10-13
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 (K161584)Asahi Intecc Co., Ltd.2016-10-06
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip (K161887)Volcano Corporation2016-09-20
S-Wire Guidewire System (K153397)Concert Medical, LLC2016-08-18
ASAHI Fielder XT-A, ASAHI Fielder XT-R (K153106)Asahi Intecc Co., Ltd.2016-06-21
Arrow Quickflash Arterial Catheterization Device (K160018)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2016-06-13
ASAHI Astato XS 40 (K153443)Asahi Intecc Co., Ltd.2016-02-25
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire (K152231)Boston Scientific Corporation2016-02-12
OptoWire Deux (K152991)Opsens2016-02-11
PW Guidewires (K152497)Tatara Vascular, LLC2016-01-22
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire (K151840)Boston Scientific Corporation2015-12-16
R350 guidewire (K151234)Vascular Solutions, Inc.2015-11-18
Radifocus Glidewire (K152740)Ashitaka Factory of Terumo Corp.2015-11-16
HI-TORQUE BALANCE (K152709)Abbott Vascular2015-10-21
Hi-Torque Command 18 Guide Wire (K152404)Abbott Vascular2015-09-21
Medtronic Confida Brecker Guidewire (K150465)Medtronic Core Valve, LLC2015-08-03
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) (K150445)Asahi Intecc Co., Ltd.2015-06-30
Opto Wire and OptoMonitor System (K142598)Opsens, Inc.2015-06-12
Pre-Formed Guidewire (K151244)Lake Region Medical2015-06-11
Heavy Double Flexible Tipped Wire Guide (K150802)Cook Incorporated2015-05-28
Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) (K143252)Needle Tech Products, Inc.2015-04-23
Attain Hybrid Guide Wire (K143316)Medtronic, Inc.2015-03-11
Spring Coil Guidewire (K143135)Neometrics, Inc.2015-02-20
ULTRASKIN HYDROPHILIC GUIDE WIRE (K141707)Lepu Medical Technology (Beijing) Co., Ltd.2015-01-21
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire (K143587)Boston Scientific Corporation2015-01-15
Hi-Torque JET Guide Wire Family (K142415)Abbott Vascular, Inc.2014-12-19
ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM (K141218)Vadiswire Corporation2014-12-18
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE (K140536)Lake Region Medical2014-12-17
PRELUDE PLASTIC JACKETED GUIDE WIRE (K142051)Merit Medical Systems, Inc.2014-12-17
MERIT HYDROPHILIC GUIDEWIRE (K141295)Merit Medical Systems, Inc.2014-12-16
DISTAL ACCESS TORQUE DEVICE (K141054)Distal Access, LLC2014-12-10
PREDICATE III GUIDEWIRE (K142393)Lake Region Medical2014-11-25
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector (K142254)St Jude Medical2014-11-13
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE (K141339)Asahi Intecc Co., Ltd.2014-10-23
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE (K140608)Merit Medical Systems, Inc.2014-09-12
HYDRAVIEW GUIDEWIRE (K141831)Brivant Limited2014-09-04
HI-TORQUE VERSATURN GUIDE WIRE (K141782)Abbott Vascular2014-08-07
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE (K140695)Medtronic, Inc.2014-06-12
INSERTION TOOL (K140673)Boston Scientific Corp2014-04-16
HYDROPHILIC COATED GUIDEWIRE (K133155)Lake Region Medical2014-04-07
MANDREL GUIDEWIRE (K140485)Lake Region Medical2014-03-27
ASAHI GAIA FIRST, SECOND, THIRD (K133865)Asahi Intecc Co., Ltd.2014-03-18
VDRIVE WITH V-SONO (K133396)Stereotaxis, Inc.2014-02-06
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE (K132623)Medtronic2013-12-19
INQWIRE DIAGNOSTIC GUIDE WIRE (K133230)Merit Medical Systems, Inc.2013-12-12
MEDIVALVE ACWIRE (K132545)Medivalve , Ltd.2013-11-08
HORIZON XVU (FFR) (K123792)Mennen Medical , Ltd.2013-08-30
PRE-FORMED GUIDEWIRES (K130798)Lake Region Medical, Inc.2013-08-23
MERIT HYDROPHILIC GUIDE WIRE (K131710)Merit Medical Systems, Inc.2013-07-29
VDRIVE W/V-SONO (K122659)Stereotaxis, Inc.2013-07-26
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE (K130766)Cook, Inc.2013-07-17
VERRATA PRESSURE GUIDE WIRE (K131288)Volcano Corporation2013-06-21
GUIDEWIRE, PURSUER SERIES (K130104)Oscor, Inc.2013-06-13
MERIT HYDROPHILIC GUIDE WIRE (K130588)Merit Medical Systems, Inc.2013-04-05
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ (K122469)Asahi Intecc Co., Ltd.2013-03-08
ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO (K122468)Asahi Intecc Co., Ltd.2013-03-08
SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY (K124007)Micro Therapeutics, Inc. D/B/A: Ev3, Inc.2013-03-07
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE (K122590)Terumo Medical Corporation2013-03-01
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE (K123707)Cook, Inc.2013-02-28
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY (K123067)Abbott Vascular, Inc.2013-01-29
MERIT HYDROPHILIC GUIDE WIRE (K123609)Merit Medical Systems, Inc.2013-01-16
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) (K121398)Guidepath Medical, Inc.2012-12-13
HI-TORQUE COMMAND GUIDE WIRE FAMILY (K122573)Abbott Vascular, Inc.2012-11-20
STINGRAY GUIDEWIRES (K122795)Bridgepoint Medical2012-11-08
TORQUE DEVICE (K123024)Boston Scientific Corporation2012-10-26
CHARTER GUIDEWIRE (K122856)Brivant, Ltd.2012-10-17
OSTIAL PRO STENT POSITIONING SYSTEM (K122089)Merit Medical Systems, Inc.2012-09-21
MERIT HYDROPHILIC GUIDE WIRE (K120644)Merit Medical Systems, Inc.2012-09-19
SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS (K122506)Surefire Medical, Inc.2012-09-17
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE (K121776)Codman & Shurtleff, Inc.2012-08-14
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