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 |
|---|---|---|---|
| Apr 11, 2018 | K172187 | Inno-Hydrowire Suzhou Innomed Medical Device Co., Ltd., CN | DQX |
| Mar 30, 2018 | K171997 | Mandril Wire Guide Cook Incorporated | DQX |
| Mar 19, 2018 | K171912 | Double Flexible Tip Wire Guides Cook Incorporated | DQX |
| Mar 9, 2018 | K171764 | Fixed Core Wire Guides Cook Incorporated | DQX |
| Feb 16, 2018 | K180128 | Warrior 14 guidewire Vascular Solutions, Inc. | DQX |
| Feb 12, 2018 | K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter Asahi Intecc Co., Ltd., JP | DQX |
| Jan 22, 2018 | K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300 Scientia Vascular, LLC | DQX |
| Jan 12, 2018 | K173795 | HI-TORQUE TurnTrac Guide Wire Family Abbott Vascular | DQX |
| Jan 10, 2018 | K171445 | Amplatz Support Wire Guide with Apex Curve Cook Incorporated | DQX |
| Jan 5, 2018 | K171948 | Roadrunner Extra Support Wire Guide Cook Incorporated | DQX |
| Dec 15, 2017 | K173532 | Raider Guidewire Vascular Solutions, Inc. | DQX |
| Dec 7, 2017 | K171513 | Lunderquist Extra Stiff Wire Guide William Cook Europe Aps, DK | DQX |
| Nov 21, 2017 | K170915 | TXM Hydrophilic Guidewire Texasmedical Technologies, Inc. | DQX |
| Nov 17, 2017 | K173423 | MR Wire Guide Wire Straight, MR Wire Guide Wire Angled Nano4imaging GmbH, DE | DQX |
| Nov 9, 2017 | K172453 | WATCHDOG Hemostasis Valve Kit Boston Scientific Corporation | DQX |
| Oct 20, 2017 | K173052 | Heraeus TMW Guidewire Heraeus Medical Components, LLC | DQX |
| Sep 15, 2017 | K170417 | Glidewire GT Terumo Corporation, JP | DQX |
| Aug 25, 2017 | K172073 | Hi-Torque Command 18 Guide Wire Abbott Vascular | DQX |
| Aug 21, 2017 | K171897 | Approach CTO Microwire Guide Cook Incorporated | DQX |
| Jul 21, 2017 | K170532 | True Form Reshapable Guide Wire Merit Medical Systems, Inc., IE | DQX |
| Jun 29, 2017 | K170684 | Firebow Wire Torque Assist Device Vesatek, LLC | DQX |
| Jun 22, 2017 | K170933 | Merit Hydrophilic Guide Wire Merit Medical Systems, Inc., IE | DQX |
| Apr 6, 2017 | K170700 | Inqwire Diagnostic Guide Wire Merit Medical Systems, Inc., IE | DQX |
| Apr 3, 2017 | K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension Asahi Intecc Co., Ltd., JP | DQX |
| Mar 22, 2017 | K170636 | Fathom-16 Steerable Guidewires Boston Scientific Corporation | DQX |
| Mar 3, 2017 | K163575 | Inqwire Diagnostic Guide Wire Merit Medical Systems, Inc., IE | DQX |
| Jan 30, 2017 | K163004 | Radifocus Glidewire Advantage Track Ashitaka Factory of Terumo Coporation, JP | DQX |
| Jan 27, 2017 | K162842 | ASAHI PTCA Guide Wire ASAHI SUOH 03 Asahi Intecc Co., Ltd., JP | DQX |
| Jan 6, 2017 | K163444 | Spectre guidewire Vascular Solutions, Inc. | DQX |
| Dec 8, 2016 | K160785 | Worker Guidewire Argon Medical Devices, Inc. | DQX |
| Dec 6, 2016 | K161702 | Endura guidewire Vascular Solutions, Inc. | DQX |
| Nov 22, 2016 | K160594 | MRWire Guide Wire Nano4imaging GmbH, DE | DQX |
| Oct 18, 2016 | K160643 | ENROUTE 0.014 Guidewire Lake Region Medical, IE | DQX |
| Oct 13, 2016 | K153685 | Sunmed Haemostatic Valves Sunny Medical Device (Shenzhen) Co., Ltd. | DQX |
| Oct 6, 2016 | K161584 | ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 Asahi Intecc Co., Ltd., JP | DQX |
| Sep 20, 2016 | K161887 | Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pres Volcano Corporation | DQX |
| Aug 18, 2016 | K153397 | S-Wire Guidewire System Concert Medical, LLC | DQX |
| Jun 21, 2016 | K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R Asahi Intecc Co., Ltd., JP | DQX |
| Jun 13, 2016 | K160018 | Arrow Quickflash Arterial Catheterization Device Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | DQX |
| Feb 25, 2016 | K153443 | ASAHI Astato XS 40 Asahi Intecc Co., Ltd., JP | DQX |
| Feb 12, 2016 | K152231 | Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire Boston Scientific Corporation | DQX |
| Feb 11, 2016 | K152991 | OptoWire Deux Opsens, CA | DQX |
| Jan 22, 2016 | K152497 | PW Guidewires Tatara Vascular, LLC | DQX |
| Dec 16, 2015 | K151840 | Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire Boston Scientific Corporation | DQX |
| Nov 18, 2015 | K151234 | R350 guidewire Vascular Solutions, Inc. | DQX |
| Nov 16, 2015 | K152740 | Radifocus Glidewire Ashitaka Factory of Terumo Corp., JP | DQX |
| Oct 21, 2015 | K152709 | HI-TORQUE BALANCE Abbott Vascular | DQX |
| Sep 21, 2015 | K152404 | Hi-Torque Command 18 Guide Wire Abbott Vascular | DQX |
| Aug 3, 2015 | K150465 | Medtronic Confida Brecker Guidewire Medtronic Core Valve, LLC | DQX |
| Jun 30, 2015 | K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) Asahi Intecc Co., Ltd., JP | DQX |
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