The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Sarns 7850 Centrifugal Pump (modified).
| Device ID | K915363 |
| 510k Number | K915363 |
| Device Name: | SARNS 7850 CENTRIFUGAL PUMP (MODIFIED) |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Contact | Nancy P Atwood |
| Correspondent | Nancy P Atwood 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-27 |
| Decision Date | 1993-07-28 |