K894784 is an FDA 510(k) clearance for the MODIFIED SHILEY FEMORAL VENOUS CANNULA. This device is classified as a Cannula, Catheter (Class II - Special Controls, product code DQR).
Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on March 28, 1990, 247 days after receiving the submission on July 24, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1300.
| 510(k) Number | K894784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1989 |
| Decision Date | March 28, 1990 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQR — Cannula, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1300 |