The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Plexus 2(tm) Infant Hollow Fiber Oxygenator.
Device ID | K901250 |
510k Number | K901250 |
Device Name: | PLEXUS 2(TM) INFANT 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 |