Panels › Cardiovascular › Product code MOF · Class 2
Guide, Wire, Catheter, Neurovasculature
Regulation 870.1330
12510(k)s in 12 months (45 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MOF
| Company | 510(k)s | Recalls |
|---|---|---|
| Asahi Intecc Co., Ltd. | 10 | 0 |
| Scientia Vascular | 9 | 0 |
| MicroVention, Inc. | 6 | 1 |
| Arbor Endovascular, LLC | 5 | 0 |
| Rapid Medical Ltd. | 3 | 0 |
| Stryker Neurovascular | 1 | 1 |
| Artiria Medical SA | 1 | 0 |
| Balt USA, LLC | 1 | 0 |
| Codman & Shurtleff, Inc. | 1 | 0 |
| Enlight Medical Technologies (Shenzhen) Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2026 | K254181 | Aristotle 65 Macrowire Scientia Vascular | MOF |
| Aug 27, 2026 | K260751 | 35 Helix Guidewire Piraeus Medical, Inc. | MOF |
| Aug 14, 2026 | K262424 | Willow 12 Guidewire Arbor Endovascular, LLC | MOF |
| Aug 6, 2026 | K260223 | Aristotle Mini Guidewire Scientia Vascular, Inc. | MOF |
| Jul 17, 2026 | K254006 | Drivewire 35 Guidewire Rapid Medical Ltd., IL | MOF |
| Apr 29, 2026 | K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire Scientia Vascular, Inc. | MOF |
| Apr 16, 2026 | K252317 | Zenith Micro Guidewire Suzhou Zenith Vascular SciTech Limited, CN | MOF |
| Mar 19, 2026 | K260537 | Willow 24 Guidewire Arbor Endovascular, LLC | MOF |
| Mar 16, 2026 | K252122 | DCwire Micro-guidewire Shanghai Achieva Medical Suzhou Co., Ltd., CN | MOF |
| Feb 13, 2026 | K260130 | Willow 18 Guidewire Arbor Endovascular, LLC | MOF |
| Feb 2, 2026 | K252011 | CHIKAI Nexus petit Asahi Intecc Co., Ltd., JP | MOF |
| Nov 26, 2025 | K253168 | 0.014 Willow Guidewire Arbor Endovascular, LLC | MOF |
| Aug 26, 2025 | K244061 | X-Wire Guidewire Imperative Care, Inc. | MOF |
| Jul 17, 2025 | K243756 | 0.014 Willow Guidewire Arbor Endovascular, LLC | MOF |
| Apr 21, 2025 | K243383 | CHIKAI Nexus 014 Asahi Intecc Co., Ltd., JP | MOF |
| Apr 1, 2025 | K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guide Scientia Vascular, Inc. | MOF |
| Nov 18, 2024 | K240871 | Synxess Neurovascular Guidewire Enlight Medical Technologies (Shenzhen) Co., Ltd., CN | MOF |
| Jul 11, 2024 | K233791 | Drivewire 24 Guidewire Rapid-Medical , Ltd., IL | MOF |
| Aug 1, 2023 | K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire Scientia Vascular, Inc. | MOF |
| Apr 24, 2023 | K222690 | SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SA, CH | MOF |
| Mar 10, 2023 | K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire Scientia Vascular, LLC | MOF |
| Jan 26, 2023 | K222437 | Aristotle Colossus Guidewire Scientia Vascular, Inc. | MOF |
| Jun 29, 2022 | K220934 | RADIFOCUS Torque Device Terumo Medical Products (Hangzhou) Co., Ltd., CN | MOF |
| Dec 14, 2020 | K200374 | Columbus Guidewire Rapid-Medical , Ltd., IL | MOF |
| Sep 25, 2020 | K202522 | Synchro SELECT Guidewire Stryker Neurovascular | MOF |
| Jul 2, 2020 | K201487 | Traxcess 7 Mini Guidewire MicroVention, Inc. | MOF |
| Apr 16, 2020 | K200547 | Traxcess 14 SELECT Guidewire MicroVention, Inc. | MOF |
| Jul 26, 2019 | K191714 | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft Asahi Intecc Co., Ltd., JP | MOF |
| May 1, 2019 | K190843 | Synchro2 Support Guidewire Stryker | MOF |
| Mar 22, 2019 | K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, Scientia Vascular, LLC | MOF |
| Jan 29, 2019 | K183070 | ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 Asahi Intecc Co., Ltd., JP | MOF |
| Oct 4, 2018 | K182337 | HYBRID Guidewire Balt USA, LLC | MOF |
| Aug 7, 2018 | K181828 | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profi Scientia Vascular, LLC | MOF |
| Jul 1, 2017 | K171613 | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip Asahi Intecc Co., Ltd., JP | MOF |
| Dec 9, 2016 | K163154 | Traxcess 7 Mini XSoft Guidewire MicroVention, Inc. | MOF |
| Oct 14, 2016 | K161912 | ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip Asahi Intecc Co., Ltd., JP | MOF |
| Sep 30, 2016 | K161803 | Traxcess .007 Mini Guidewire MicroVention, Inc. | MOF |
| Apr 7, 2016 | K160659 | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) Asahi Intecc Co., Ltd. | MOF |
| Dec 29, 2015 | K153053 | Traxcess Pro 14 Guidewire MicroVention, Inc. | MOF |
| Nov 16, 2015 | K151825 | Viradius Neurowire Mivi Neuroscience, Inc. | MOF |
| Jan 30, 2015 | K141751 | ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR Asahi Intecc Co., Ltd. | MOF |
| Jul 31, 2014 | K133725 | TRAXCESS 14 GUIDEWIRE MicroVention, Inc. | MOF |
| Feb 24, 2014 | K133625 | AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & Codman & Shurtleff, Inc. | MOF |
| Dec 1, 2011 | K112979 | ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE Asahi Intecc Co., Ltd. | MOF |
| Aug 22, 2011 | K110584 | ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE Asahi Intecc Co., Ltd. | MOF |
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