The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Bcd Advanced Blood Carioplegia Systems.
| Device ID | K925369 |
| 510k Number | K925369 |
| Device Name: | BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine, CA 92713 |
| Contact | Donna Free |
| Correspondent | Donna Free SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine, CA 92713 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-23 |
| Decision Date | 1993-03-26 |