The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Expanded Use For Shiley 3l Cardiotomy Reservoir.
| Device ID | K872721 |
| 510k Number | K872721 |
| Device Name: | EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Ganz Pobuda |
| Correspondent | Ganz Pobuda 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 | 1987-07-10 |
| Decision Date | 1987-09-23 |