510(k) K915363
K915363 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)". The FDA issued a decision of Substantially Equivalent on July 28, 1993. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1993
- Date Received
- November 27, 1991
- 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