FDA Product Code
FDA Product Code MOF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1330
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254181 | Aristotle 65 Macrowire | Scientia Vascular | 2026-09-16 | Traditional | PDF ↗ |
| K260751 | 35 Helix Guidewire | Piraeus Medical, Inc. | 2026-08-27 | Traditional | PDF ↗ |
| K262424 | Willow 12 Guidewire | Arbor Endovascular, LLC | 2026-08-14 | Special | PDF ↗ |
| K260223 | Aristotle Mini Guidewire | Scientia Vascular, Inc. | 2026-08-06 | Traditional | PDF ↗ |
| K254006 | Drivewire 35 Guidewire | Rapid Medical Ltd. | 2026-07-17 | Traditional | PDF ↗ |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, Inc. | 2026-04-29 | Traditional | PDF ↗ |
| K252317 | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | 2026-04-16 | Traditional | PDF ↗ |
| K260537 | Willow 24 Guidewire | Arbor Endovascular, LLC | 2026-03-19 | Special | PDF ↗ |
| K252122 | DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. | 2026-03-16 | Traditional | PDF ↗ |
| K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | 2026-02-13 | Special | PDF ↗ |
| K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | 2026-02-02 | Traditional | PDF ↗ |
| K253168 | 0.014 Willow Guidewire | Arbor Endovascular, LLC | 2025-11-26 | Special | PDF ↗ |
| K244061 | X-Wire Guidewire | Imperative Care, Inc. | 2025-08-26 | Traditional | PDF ↗ |
| K243756 | 0.014 Willow Guidewire | Arbor Endovascular, LLC | 2025-07-17 | Traditional | PDF ↗ |
| K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | 2025-04-21 | Traditional | PDF ↗ |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | Scientia Vascular, Inc. | 2025-04-01 | Special | PDF ↗ |
| K240871 | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | 2024-11-18 | Traditional | PDF ↗ |
| K233791 | Drivewire 24 Guidewire | Rapid-Medical , Ltd. | 2024-07-11 | Traditional | PDF ↗ |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. | 2023-08-01 | Special | PDF ↗ |
| K222690 | SmartGUIDE deflectable hydrophilic guidewire | Artiria Medical SA | 2023-04-24 | Traditional | PDF ↗ |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, LLC | 2023-03-10 | Special | PDF ↗ |
| K222437 | Aristotle Colossus Guidewire | Scientia Vascular, Inc. | 2023-01-26 | Traditional | PDF ↗ |
| K220934 | RADIFOCUS Torque Device | Terumo Medical Products (Hangzhou) Co., Ltd. | 2022-06-29 | Traditional | PDF ↗ |
| K200374 | Columbus Guidewire | Rapid-Medical , Ltd. | 2020-12-14 | Traditional | PDF ↗ |
| K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | 2020-09-25 | Special | PDF ↗ |
| K201487 | Traxcess 7 Mini Guidewire | MicroVention, Inc. | 2020-07-02 | Special | PDF ↗ |
| K200547 | Traxcess 14 SELECT Guidewire | MicroVention, Inc. | 2020-04-16 | Special | PDF ↗ |
| K191714 | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft | Asahi Intecc Co., Ltd. | 2019-07-26 | Special | PDF ↗ |
| K190843 | Synchro2 Support Guidewire | Stryker | 2019-05-01 | Special | PDF ↗ |
| K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile | Scientia Vascular, LLC | 2019-03-22 | Traditional | PDF ↗ |
| K183070 | ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 | Asahi Intecc Co., Ltd. | 2019-01-29 | Traditional | PDF ↗ |
| K182337 | HYBRID Guidewire | Balt USA, LLC | 2018-10-04 | Traditional | PDF ↗ |
| K181828 | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile | Scientia Vascular, LLC | 2018-08-07 | Special | PDF ↗ |
| K171613 | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip | Asahi Intecc Co., Ltd. | 2017-07-01 | Special | PDF ↗ |
| K163154 | Traxcess 7 Mini XSoft Guidewire | MicroVention, Inc. | 2016-12-09 | Special | PDF ↗ |
| K161912 | ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip | Asahi Intecc Co., Ltd. | 2016-10-14 | Special | PDF ↗ |
| K161803 | Traxcess .007 Mini Guidewire | MicroVention, Inc. | 2016-09-30 | Special | PDF ↗ |
| K160659 | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) | Asahi Intecc Co., Ltd. | 2016-04-07 | Special | PDF ↗ |
| K153053 | Traxcess Pro 14 Guidewire | MicroVention, Inc. | 2015-12-29 | Special | PDF ↗ |
| K151825 | Viradius Neurowire | Mivi Neuroscience, Inc. | 2015-11-16 | Traditional | PDF ↗ |
| K141751 | ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR | Asahi Intecc Co., Ltd. | 2015-01-30 | Traditional | PDF ↗ |
| K133725 | TRAXCESS 14 GUIDEWIRE | MicroVention, Inc. | 2014-07-31 | Traditional | PDF ↗ |
| 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. | 2014-02-24 | Special | PDF ↗ |
| K112979 | ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE | Asahi Intecc Co., Ltd. | 2011-12-01 | Traditional | PDF ↗ |
| K110584 | ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE | Asahi Intecc Co., Ltd. | 2011-08-22 | Traditional | PDF ↗ |
Product code MOF · Class II · Cardiovascular. Data: openFDA.