K930758 is an FDA 510(k) clearance for the DIAGNOSTIC INTRAVASCULAR CATHETER. 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 September 24, 1993, 224 days after receiving the submission on February 12, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K930758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1993 |
| Decision Date | September 24, 1993 |
| Days to Decision | 224 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 |