The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Integrated Cardioplegia Deliv. Sys.
| Device ID | K810079 |
| 510k Number | K810079 |
| Device Name: | SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-13 |
| Decision Date | 1981-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753002000 | K810079 | 000 |
| 50699753001966 | K810079 | 000 |
| 50699753001959 | K810079 | 000 |
| 50699753001942 | K810079 | 000 |
| 50699753001218 | K810079 | 000 |