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 |