The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Retrograde Cardioplegia Delivery System.
Device ID | K853516 |
510k Number | K853516 |
Device Name: | SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM |
Classification | Heat-exchanger, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Contact | Marshall Smith |
Correspondent | Marshall Smith 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 | 1985-08-22 |
Decision Date | 1985-11-14 |