510(k) K781383
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1978
- Date Received
- August 11, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4270
- Review Panel
- CV
- Submission Type