MOF
- Product code
- MOF
- Device name
- Guide, Wire, Catheter, Neurovasculature
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1330
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 17
- Summaries archived here
- 17 (direct download)
- 510(k) clearances (all years, FDA)
- 44 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260751 | 2026-08-27 | Piraeus Medical, Inc. | 35 Helix Guidewire | |
| K262424 | 2026-08-14 | Arbor Endovascular, LLC | Willow 12 Guidewire | |
| K260223 | 2026-08-06 | Scientia Vascular, Inc. | Aristotle Mini Guidewire | |
| K254006 | 2026-07-17 | Rapid Medical Ltd. | Drivewire 35 Guidewire | |
| K253579 | 2026-04-29 | Scientia Vascular, Inc. | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aris… | |
| K252317 | 2026-04-16 | Suzhou Zenith Vascular SciTech Limited | Zenith Micro Guidewire | |
| K260537 | 2026-03-19 | Arbor Endovascular, LLC | Willow 24 Guidewire | |
| K252122 | 2026-03-16 | Shanghai Achieva Medical Suzhou Co., L… | DCwire Micro-guidewire | |
| K260130 | 2026-02-13 | Arbor Endovascular, LLC | Willow 18 Guidewire | |
| K252011 | 2026-02-02 | Asahi Intecc Co., Ltd. | CHIKAI Nexus petit | |
| K253168 | 2025-11-26 | Arbor Endovascular, LLC | 0.014 Willow Guidewire | |
| K244061 | 2025-08-26 | Imperative Care, Inc. | X-Wire Guidewire | |
| K243756 | 2025-07-17 | Arbor Endovascular, LLC | 0.014 Willow Guidewire | |
| K243383 | 2025-04-21 | Asahi Intecc Co., Ltd. | CHIKAI Nexus 014 | |
| K243938 | 2025-04-01 | Scientia Vascular, Inc. | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aris… | |
| K240871 | 2024-11-18 | Enlight Medical Technologies (Shenzhen… | Synxess Neurovascular Guidewire | |
| K233791 | 2024-07-11 | Rapid-Medical , Ltd. | Drivewire 24 Guidewire |
Official FDA classification page: MOF
Classification and pathway per current FDA publications. Data from openFDA (CC0).