The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Femoral Cannulae Introducer Kit.
| Device ID | K881073 |
| 510k Number | K881073 |
| Device Name: | SHILEY FEMORAL CANNULAE INTRODUCER KIT |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Radine Pobuda |
| Correspondent | Radine Pobuda SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-14 |
| Decision Date | 1988-06-09 |