K894681 is an FDA 510(k) clearance for the REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on October 12, 1989, 79 days after receiving the submission on July 25, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K894681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1989 |
| Decision Date | October 12, 1989 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXE — Catheter, Embolectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |