The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Modified Shiley Femoral Arterial Cannula.
Device ID | K884393 |
510k Number | K884393 |
Device Name: | MODIFIED SHILEY FEMORAL ARTERIAL CANNULA |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Contact | Merritt M Girgis |
Correspondent | Merritt M Girgis 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 | 1988-10-11 |
Decision Date | 1988-12-27 |