510(k) K894268
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1989
- Date Received
- June 22, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Cardiopulmonary Bypass (Vein Marker)
- Device Class
- Class II
- Regulation Number
- 870.3450
- Review Panel
- CV
- Submission Type