510(k) K830150
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1983
- Date Received
- January 17, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suction Control, Intracardiac, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4430
- Review Panel
- CV
- Submission Type