The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Modified Shiley Femoral Venous Cannula.
| Device ID | K894784 |
| 510k Number | K894784 |
| Device Name: | MODIFIED SHILEY FEMORAL VENOUS CANNULA |
| Classification | Cannula, Catheter |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Louis J Mazzarese |
| Correspondent | Louis J Mazzarese SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DQR |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1990-03-28 |