The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Stockert-shiley Venous Cath & Aortic Arch Cannula.
| Device ID | K861496 |
| 510k Number | K861496 |
| Device Name: | STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Morton Barak |
| Correspondent | Morton Barak 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 | 1986-04-22 |
| Decision Date | 1986-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178000100 | K861496 | 000 |
| 38033178000025 | K861496 | 000 |
| 38033178000032 | K861496 | 000 |
| 38033178000049 | K861496 | 000 |
| 38033178000056 | K861496 | 000 |
| 38033178000063 | K861496 | 000 |
| 38033178000070 | K861496 | 000 |
| 38033178000087 | K861496 | 000 |
| 38033178000094 | K861496 | 000 |
| 38033178000018 | K861496 | 000 |