510(k) K952879
K952879 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT". The FDA issued a decision of Substantially Equivalent on Apr 22, 1996. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 22, 1996
- Date Received
- Jun 23, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device Class
- Class II
- Regulation Number
- 870.4360
- Review Panel
- CV
- Submission Type
- 510(k)