510(k) K980762
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 1998
- Date Received
- February 27, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Device Class
- Class II
- Regulation Number
- 870.4260
- Review Panel
- CV
- Submission Type