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 |
|---|---|---|---|
| Jul 1, 2022 | K213315 | CROSSLEAD Peripheral Guide Wire Asahi Intecc Co., Ltd., JP | DQX |
| Jun 30, 2022 | K213949 | VASSALLO GT 018 Floppy Filmecc Co., Ltd., JP | DQX |
| May 27, 2022 | K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT FMD Co., Ltd., JP | DQX |
| May 17, 2022 | K210548 | Medline Integrated Arterial Catheter Centurion Medical Products | DQX |
| Apr 19, 2022 | K220075 | Spartan Center Wire Spartan Micro, Inc. | DQX |
| Mar 18, 2022 | K213834 | Cardio Flow Peripheral Guide Wire Cardio Flow Inc., | DQX |
| Feb 17, 2022 | K220137 | Lunderquist Extra Stiff Wire Guide William Cook Europe Aps, DK | DQX |
| Feb 9, 2022 | K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire Vascular Solutions, LLC | DQX |
| Dec 8, 2021 | K211898 | ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 Asahi Intecc Co., Ltd., JP | DQX |
| Nov 22, 2021 | K211741 | Pre-Formed Extra Support Guidewire Lake Region Medical | DQX |
| May 4, 2021 | K203529 | VASSALLO GT Hybrid Filmecc Co., Ltd., JP | DQX |
| Apr 21, 2021 | K203533 | VASSALLO GT Filmecc Co., Ltd., JP | DQX |
| Apr 15, 2021 | K210235 | Verrata PLUS Pressure Guide Wire Volcano Corporation | DQX |
| Feb 18, 2021 | K201720 | LiPPS Analyzer, LiPPS Wire Pressure Guide Wire Beijing Bywave Sensing Medical Technology Co., Ltd., CN | DQX |
| Oct 14, 2020 | K201595 | Merit Hydrophilic Guide Wire Merit Medical Systems, Inc., IE | DQX |
| Sep 28, 2020 | K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip Volcano Corporation | DQX |
| Aug 26, 2020 | K193653 | Hydrophilic Coating Guide Wire Suzhou Hengrui Disheng Medical Co., Ltd., CN | DQX |
| Jul 30, 2020 | K201834 | HI-TORQUE PROCEED Guide Wire Family Abbott Vascular | DQX |
| Jul 29, 2020 | K201760 | Zoom 14 Guidewire Scientia Vascular, LLC | DQX |
| Jul 21, 2020 | K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQX |
| May 7, 2020 | K200120 | LiteSaber Wire Torque Assist Device Vesatek, LLC | DQX |
| Apr 8, 2020 | K200144 | HI-TORQUE Steelcore Bare Guide Wire Abbott Vascular | DQX |
| Apr 8, 2020 | K193571 | Go2Wire Guide Wire Merit Medical System, Inc., IE | DQX |
| Mar 26, 2020 | K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip Volcano Corporation | DQX |
| Jan 18, 2020 | K193548 | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQX |
| Jan 15, 2020 | K192454 | Wattson Temporary Pacing Guidewire Vascular Solutions | DQX |
| Jan 2, 2020 | K192599 | ASAHI PTCA Guide Wire ASAHI Gaia Next Asahi Intecc Co., Ltd., JP | DQX |
| Jan 2, 2020 | K191907 | OptoWire III Opsens, Inc., CA | DQX |
| Dec 13, 2019 | K193194 | CrossTorq 14 Guidewire Scientia Cardio Access, LLC | DQX |
| Dec 11, 2019 | K193126 | HI-TORQUE InfilTrac Guide Wire Family Abbott Vascular | DQX |
| Nov 26, 2019 | K191502 | Heraeus Peripheral Guidewire Heraeus Medical Components, LLC | DQX |
| Nov 21, 2019 | K191464 | Asahi PTCA Guide Wire Asahi SION Series Asahi Intecc Co., Ltd., JP | DQX |
| Oct 30, 2019 | K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, Scientia Vascular, LLC | DQX |
| Oct 9, 2019 | K191687 | pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire Phenox Limited, IE | DQX |
| Aug 1, 2019 | K190176 | MINAMO Asahi Intecc Co., Ltd., JP | DQX |
| Jul 22, 2019 | K182985 | Roadrunner PC Wire Guide, Olcott Torque Device Cook Incorporated | DQX |
| Jul 1, 2019 | K183062 | ASAHI Silverway Asahi Intecc Co., Ltd., JP | DQX |
| Apr 18, 2019 | K182457 | Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vekt Brivant Limited (Lake Region Medical), IE | DQX |
| Mar 11, 2019 | K182553 | Inno-Pathwire Suzhou Innomed Medical Device Co., Ltd., CN | DQX |
| Feb 15, 2019 | K181353 | Lunderquist® Fixed Core Wire Guide Cook Incorporated | DQX |
| Jan 11, 2019 | K183467 | Roadrunner Extra Support Wire Guide Cook Incorporated | DQX |
| Dec 20, 2018 | K180830 | Reuter Tip Deflecting Wire Guide Cook Incorporated | DQX |
| Sep 26, 2018 | K182315 | Magic Torque DLVR Guidewire Boston Scientific Corporation | DQX |
| Jul 20, 2018 | K181647 | Bandit guidewire Vascular Solutions, Inc. | DQX |
| Jul 18, 2018 | K180784 | ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES Asahi Intecc Co., Ltd., JP | DQX |
| Jul 5, 2018 | K173277 | ASAHI PTCA Guide Wire ASAHI SION black Asahi Intecc Co., Ltd., JP | DQX |
| Jun 18, 2018 | K180726 | Savion DLVR Guidewire, Savion FLX Guidewire Boston Scientific, Inc. | DQX |
| Jun 14, 2018 | K181351 | Double Flexible Tipped Wire Guides Cook Incorporated | DQX |
| May 3, 2018 | K181001 | Medtronic Confida Brecker Guidewire Medtronic Core Valve, LLC, IE | DQX |
| Apr 12, 2018 | K180795 | JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire Boston Scientific | DQX |
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