The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Modified Shiley Dual Lumen Subclavian Cannula.
| Device ID | K881290 |
| 510k Number | K881290 |
| Device Name: | MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA |
| Classification | Catheter, Subclavian |
| 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 | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-28 |
| Decision Date | 1988-04-27 |