The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Plexus 2 & 3.5 Hollow Fiber Oxygenators.
Device ID | K931444 |
510k Number | K931444 |
Device Name: | PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS |
Classification | Oxygenator, 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 | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-22 |
Decision Date | 1994-05-27 |