The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Blood Pump-mode S10k.
| Device ID | K780410 |
| 510k Number | K780410 |
| Device Name: | BLOOD PUMP-MODE S10K |
| Classification | Pump, Blood, Extra-luminal |
| Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIR |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-13 |
| Decision Date | 1978-05-03 |