The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Plexus 3.5(tm) Pediatric Hollow Fiber Oxygenator.
| Device ID | K901249 |
| 510k Number | K901249 |
| Device Name: | PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Abati, Phd |
| Correspondent | Abati, Phd SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-16 |
| Decision Date | 1990-06-11 |