K050808 is an FDA 510(k) clearance for the CORONARY SINUS ACCESS KIT, MODEL KCS8F-01. This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by Cardio-Optics, Inc. (Boulder, US). The FDA issued a Cleared decision on July 28, 2005, 120 days after receiving the submission on March 30, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K050808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2005 |
| Decision Date | July 28, 2005 |
| Days to Decision | 120 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 |