The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Ionescu-shiley Pericardial Xenograft (isu).
| Device ID | K871596 |
| 510k Number | K871596 |
| Device Name: | IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) |
| Classification | Holder, Heart-valve, Prosthesis |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Radine Pobuda |
| Correspondent | Radine Pobuda SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DTJ |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-24 |
| Decision Date | 1987-06-15 |