The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Ngbcd & Ngbcdp Cardioplegia Delivery Systems.
| Device ID | K934847 |
| 510k Number | K934847 |
| Device Name: | NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS |
| Classification | Reservoir, Blood, 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 | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-08 |
| Decision Date | 1994-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178250628 | K934847 | 000 |
| 38033178250611 | K934847 | 000 |
| 38033178250604 | K934847 | 000 |
| 38033178250598 | K934847 | 000 |
| 38033178250581 | K934847 | 000 |