The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Modified Stockert-shiley Venous Catheter.
| Device ID | K890980 |
| 510k Number | K890980 |
| Device Name: | MODIFIED STOCKERT-SHILEY VENOUS CATHETER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | M Girgis |
| Correspondent | 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 | 1989-02-27 |
| Decision Date | 1989-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178004573 | K890980 | 000 |
| 38033178000179 | K890980 | 000 |
| 38033178000223 | K890980 | 000 |
| 38033178000230 | K890980 | 000 |
| 38033178000247 | K890980 | 000 |
| 38033178004528 | K890980 | 000 |
| 38033178004535 | K890980 | 000 |
| 38033178004542 | K890980 | 000 |
| 38033178004559 | K890980 | 000 |
| 38033178004566 | K890980 | 000 |
| 38033178000162 | K890980 | 000 |