The following data is part of a premarket notification filed by 3m Company with the FDA for Sarns Miniprime Cardioplegia Set W/conducer(tm).
| Device ID | K897039 |
| 510k Number | K897039 |
| Device Name: | SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM) |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | 3M COMPANY 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Contact | James Balun |
| Correspondent | James Balun 3M COMPANY 6200 JACKSON RD. P.O. 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 | 1989-12-18 |
| Decision Date | 1990-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753009085 | K897039 | 000 |