510(k) K163618
Clearance Details
- Decision
- SESU ()
- Decision Date
- May 24, 2017
- Date Received
- December 22, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coronary Mechanical Thrombectomy With Aspiration
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.