The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Stockert Caps1 Cardioplegic Control Module.
Device ID | K925661 |
510k Number | K925661 |
Device Name: | STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE |
Classification | Detector, Bubble, Cardiopulmonary Bypass |
Applicant | SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine, CA 92713 |
Contact | David Taylor |
Correspondent | David Taylor SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine, CA 92713 |
Product Code | KRL |
CFR Regulation Number | 870.4205 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-10 |
Decision Date | 1993-05-18 |