The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Sorin Blood Cardioplegia Console.
| Device ID | K942582 |
| 510k Number | K942582 |
| Device Name: | SORIN BLOOD CARDIOPLEGIA CONSOLE |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92614 -5751 |
| Contact | Ronald S Warren |
| Correspondent | Ronald S Warren SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92614 -5751 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-01 |
| Decision Date | 1995-01-27 |