The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Plexus(r) Venous Reservoir, Pvr1200.
| Device ID | K911876 |
| 510k Number | K911876 |
| Device Name: | SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Allan L Abati |
| Correspondent | Allan L Abati 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 | 1991-04-29 |
| Decision Date | 1991-08-09 |