K951721 is an FDA 510(k) clearance for the APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE. This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on July 11, 1995, 88 days after receiving the submission on April 14, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K951721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1995 |
| Decision Date | July 11, 1995 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LYK — Angioscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |