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 |