Wire, Guide, Catheter
FDA product code DQX · 735 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1330
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-12-10 – 2026-09-18
DQX
2018-03-30
DQX
2018-03-19
Double Flexible Tip Wire Guides
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DQX
2018-03-09
Fixed Core Wire Guides
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DQX
2018-02-16
Warrior 14 guidewire
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DQX
2018-02-12
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
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DQX
2018-01-22
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile
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DQX
2018-01-12
HI-TORQUE TurnTrac Guide Wire Family
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DQX
2018-01-10
Amplatz Support Wire Guide with Apex Curve
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DQX
2018-01-05
Roadrunner Extra Support Wire Guide
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DQX
2017-12-15
Raider Guidewire
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DQX
2017-12-07
Lunderquist Extra Stiff Wire Guide
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DQX
2017-11-21
TXM Hydrophilic Guidewire
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DQX
2017-11-17
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
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DQX
2017-11-09
WATCHDOG Hemostasis Valve Kit
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DQX
2017-10-20
Heraeus TMW Guidewire
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DQX
2017-09-15
Glidewire GT
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DQX
2017-08-25
Hi-Torque Command 18 Guide Wire
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DQX
2017-08-21
Approach CTO Microwire Guide
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DQX
2017-07-21
True Form Reshapable Guide Wire
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DQX
2017-06-29
Firebow Wire Torque Assist Device
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DQX
2017-06-22
Merit Hydrophilic Guide Wire
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DQX
2017-04-06
Inqwire Diagnostic Guide Wire
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DQX
2017-04-03
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
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DQX
2017-03-22
Fathom-16 Steerable Guidewires
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DQX
2017-03-03
Inqwire Diagnostic Guide Wire
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DQX
2017-01-30
Radifocus Glidewire Advantage Track
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DQX
2017-01-27
ASAHI PTCA Guide Wire ASAHI SUOH 03
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DQX
2017-01-06
Spectre guidewire
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DQX
2016-12-08
Worker Guidewire
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DQX
2016-12-06
Endura guidewire
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DQX
2016-11-22
MRWire Guide Wire
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DQX
2016-10-18
ENROUTE 0.014 Guidewire
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DQX
2016-10-13
Sunmed Haemostatic Valves
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DQX
2016-10-06
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
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DQX
2016-09-20
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
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DQX
2016-08-18
S-Wire Guidewire System
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DQX
2016-06-21
ASAHI Fielder XT-A, ASAHI Fielder XT-R
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DQX
2016-06-13
Arrow Quickflash Arterial Catheterization Device
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DQX
2016-02-25
ASAHI Astato XS 40
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DQX
2016-02-12
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
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DQX
2016-02-11
OptoWire Deux
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DQX
2016-01-22
PW Guidewires
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DQX
2013-12-19
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
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DQX
2013-12-12
INQWIRE DIAGNOSTIC GUIDE WIRE
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DQX
2013-11-08
MEDIVALVE ACWIRE
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DQX
2013-08-30
HORIZON XVU (FFR)
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DQX
2013-08-23
PRE-FORMED GUIDEWIRES
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DQX
2013-07-29
MERIT HYDROPHILIC GUIDE WIRE
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DQX
2013-07-26
VDRIVE W/V-SONO
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DQX
2013-07-17
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
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DQX
2013-06-21
VERRATA PRESSURE GUIDE WIRE
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DQX
2013-06-13
GUIDEWIRE, PURSUER SERIES
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DQX
2013-04-05
MERIT HYDROPHILIC GUIDE WIRE
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DQX
2013-03-08
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
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DQX
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
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DQX
2013-03-07
SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
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DQX
2013-03-01
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
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DQX
2013-02-28
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
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DQX
2013-01-29
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
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DQX
2013-01-16
MERIT HYDROPHILIC GUIDE WIRE
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DQX
2012-12-13
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
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DQX
2012-11-20
HI-TORQUE COMMAND GUIDE WIRE FAMILY
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DQX
2012-11-08
STINGRAY GUIDEWIRES
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DQX
2012-10-26
TORQUE DEVICE
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DQX
2012-10-17
CHARTER GUIDEWIRE
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DQX
2012-09-21
OSTIAL PRO STENT POSITIONING SYSTEM
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DQX
2012-09-19
MERIT HYDROPHILIC GUIDE WIRE
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DQX
2012-09-17
SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
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DQX
2012-08-14
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
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DQX
2012-07-20
DISPOSABLE TORQUE DEVICE
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DQX
2012-07-20
SLIDEWIRETM(TRADEMARK PENDING)
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DQX
2012-07-13
MANTARAY GUIDEWIRES
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DQX
2012-07-06
NAVIS TORQUER
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DQX
2012-05-11
SUNMED GUIDE WIRE
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DQX
2012-05-08
CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
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DQX
2012-04-19
WHOLEY GUIDE WIRE SYSTEM
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DQX
2012-04-18
MANTARAY GUIDEWIRES
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DQX
2012-02-24
14 WIRE STANDARD, 14 WIRE LS
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DQX
2012-02-14
VICTORY GUIDEWIRE (32 MODELS)
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DQX
2012-02-06
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
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DQX
2011-11-08
HI-TORQUE POWERTURN
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DQX
2011-11-03
HI TORQUE CONNECT GUIDEWIRE
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DQX
2011-10-27
VSI GUIDEWIRE
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DQX
2011-10-18
V-14 CONTROL WIRE GUIDEWIRE
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DQX
2011-09-09
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
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DQX
2011-08-02
ANCHORWIRE GUIDEWIRE
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DQX
2011-08-01
PRIMEWIRE PRESTIGE PLUS
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DQX
2011-06-30
FATHOM (TM) 14 STEERABLE GUIDEWIRE
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DQX
2011-06-30
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
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DQX
2011-06-30
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
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DQX
2011-05-18
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
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DQX
2011-04-08
ACUITY WHISPER VIEW GUIDE WIRES
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DQX
2011-03-18
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
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DQX
2011-03-07
ASAHI GUIDE WIRE EXTENSION 165CM
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DQX
2011-02-25
ENDOLOGIX GUIDEWIRE
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DQX
2011-02-25
APPROACH PRO ST WIRE GUIDE
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DQX
2011-02-10
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
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DQX
2011-02-02
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
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DQX
2010-12-03
MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
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DQX
2010-11-19
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
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