The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Mp4 Cardioplegia Delivery System.
| Device ID | K883071 |
| 510k Number | K883071 |
| Device Name: | SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Contact | Patti Parrott |
| Correspondent | Patti Parrott 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-20 |
| Decision Date | 1988-12-05 |