K913129 is an FDA 510(k) clearance for the ANGIOLAZ ANGIOSCOPE CATHETER. This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by Angiolaz, Inc. (Rockingham, US). The FDA issued a Cleared decision on December 27, 1991, 164 days after receiving the submission on July 16, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K913129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1991 |
| Decision Date | December 27, 1991 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | LYK — Angioscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |