510(k) K081573
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2008
- Date Received
- June 5, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Embolectomy
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type