K905083 is an FDA 510(k) clearance for the 4.5F IMAGECATH ANGIOSCOPE. This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on June 21, 1991, 220 days after receiving the submission on November 13, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K905083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1990 |
| Decision Date | June 21, 1991 |
| Days to Decision | 220 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 |