The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 8000 Delphin Ii Centri Pump Mod W/integr Bat.
| Device ID | K915547 |
| 510k Number | K915547 |
| Device Name: | SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Contact | James Balun |
| Correspondent | James Balun 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO 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 | 1991-12-11 |
| Decision Date | 1993-09-09 |