The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Dideco-shiley Autotransfusion Cardiotomy Reservoir.
| Device ID | K884872 |
| 510k Number | K884872 |
| Device Name: | DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Merritt M Girgis |
| Correspondent | Merritt M Girgis SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-21 |
| Decision Date | 1989-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178105393 | K884872 | 000 |
| 38033178105386 | K884872 | 000 |