K092118 is an FDA 510(k) clearance for the ANGIOGRAPHIC CATHETER, MODEL ANGIOS. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 13, 2010, 183 days after receiving the submission on July 14, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K092118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2009 |
| Decision Date | January 13, 2010 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQO - Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |