The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Hardshell Venous Reservoir W/int.
| Device ID | K843232 |
| 510k Number | K843232 |
| Device Name: | SHILEY HARDSHELL VENOUS RESERVOIR W/INT |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVENUE Irvine , CA 92714 - |
| Contact | Karen Salinas |
| Correspondent | Karen Salinas SHILEY, INC. 17600 GILLETTE AVENUE 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 | 1984-08-17 |
| Decision Date | 1985-01-14 |