The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Venomidicard Pediatric Venous Reservoir With Integralcardiotomy Filter/midicard Pediatric Cardiotomy Reservoir With Filt.
| Device ID | K964907 |
| 510k Number | K964907 |
| Device Name: | VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92713 -9503 |
| Contact | Richard J Derisio |
| Correspondent | Richard J Derisio SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92713 -9503 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-09 |
| Decision Date | 1997-08-21 |
| Summary: | summary |