The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Delphin Ii Centrifugal System.
| Device ID | K913176 |
| 510k Number | K913176 |
| Device Name: | DELPHIN II CENTRIFUGAL SYSTEM |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Contact | Nancy P Atwood |
| Correspondent | Nancy P Atwood 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 | 1991-07-17 |
| Decision Date | 1991-11-07 |