K082736 is an FDA 510(k) clearance for the RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on September 24, 2008, 6 days after receiving the submission on September 18, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K082736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2008 |
| Decision Date | September 24, 2008 |
| Days to Decision | 6 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |