510(k) 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 by
Scientia Vascular, LLC
— Product Code MOF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2018
- Date Received
- July 9, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Guide, Wire, Catheter, Neurovasculature
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- NE
- Submission Type