K894459 is an FDA 510(k) clearance for the ANGIOSCOPE. This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on March 7, 1990, 232 days after receiving the submission on July 18, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K894459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1989 |
| Decision Date | March 07, 1990 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | LYK — Angioscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |