The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Perfusion Tubing Sets.
| Device ID | K920594 |
| 510k Number | K920594 |
| Device Name: | SHILEY PERFUSION TUBING SETS |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Amy Boucly |
| Correspondent | Amy Boucly SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-11 |
| Decision Date | 1993-03-18 |