MOF — Guide, Wire, Catheter, Neurovasculature Class II
FDA Device Classification
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 |
|---|
| 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 |
| K202522 | stryker neurovascular | Synchro SELECT Guidewire | September 25, 2020 |
| K201487 | microvention | Traxcess 7 Mini Guidewire | July 2, 2020 |
| K200547 | microvention | Traxcess 14 SELECT Guidewire | April 16, 2020 |
| K191714 | asahi intecc co | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft | July 26, 2019 |
| K190843 | stryker | Synchro2 Support Guidewire | May 1, 2019 |