510(k) K964374
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 1997
- Date Received
- November 1, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4210
- Review Panel
- CV
- Submission Type