The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Sorin Bcd Advanced Pediatric Blood Cardioplegia Systems.
| Device ID | K936183 |
| 510k Number | K936183 |
| Device Name: | SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92614 -5751 |
| Contact | Ron Warren |
| Correspondent | Ron Warren SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92614 -5751 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-27 |
| Decision Date | 1994-03-23 |