510(k) K112382
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2011
- Date Received
- August 18, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Aspiration Thrombectomy Catheter
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.