MOF — Guide, Wire, Catheter, Neurovasculature Class II
FDA product code MOF covers "Guide, Wire, Catheter, Neurovasculature", a Class II medical device regulated under 21 CFR 870.1330. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MOF
- Device Class
- Class II
- Regulation Number
- 870.1330
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254006 | rapid medical | Drivewire 35 Guidewire | July 17, 2026 |
| K253579 | scientia vascular | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wir | April 29, 2026 |
| K252317 | suzhou zenith vascular scitech limited | Zenith Micro Guidewire | April 16, 2026 |
| K260537 | arbor endovascular | Willow 24 Guidewire | March 19, 2026 |
| K252122 | shanghai achieva medical suzhou co | DCwire Micro-guidewire | March 16, 2026 |
| K260130 | arbor endovascular | Willow 18 Guidewire | February 13, 2026 |
| K252011 | asahi intecc co | CHIKAI Nexus petit | February 2, 2026 |
| K253168 | arbor endovascular | 0.014 Willow Guidewire | November 26, 2025 |
| K244061 | imperative care | X-Wire Guidewire | August 26, 2025 |
| K243756 | arbor endovascular | 0.014 Willow Guidewire | July 17, 2025 |
| K243383 | asahi intecc co | CHIKAI Nexus 014 | April 21, 2025 |
| K243938 | scientia vascular | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wir | April 1, 2025 |
| K240871 | enlight medical technologies (shenzhen) co | Synxess Neurovascular Guidewire | November 18, 2024 |
| K233791 | rapid-medical | Drivewire 24 Guidewire | July 11, 2024 |
| K231954 | scientia vascular | Aristotle 18 Guidewire; Aristotle 24 Guidewire | August 1, 2023 |
| K222690 | artiria medical | SmartGUIDE deflectable hydrophilic guidewire | April 24, 2023 |
| K220398 | scientia vascular | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 | March 10, 2023 |
| K222437 | scientia vascular | Aristotle Colossus Guidewire | January 26, 2023 |
| K220934 | terumo medical products (hangzhou) co | RADIFOCUS Torque Device | June 29, 2022 |
| K200374 | rapid-medical | Columbus Guidewire | December 14, 2020 |