The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Preassembled Surgical Wash Set 122,175,225,375aa.
| Device ID | K881691 |
| 510k Number | K881691 |
| Device Name: | PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA |
| Classification | Catheter, Cannula And Tubing, Vascular, 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 | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-19 |
| Decision Date | 1988-07-05 |