K081052 is an FDA 510(k) clearance for the OCCLUSION BALLOON CATHETER, MODEL VENOS. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 18, 2008, 65 days after receiving the submission on April 14, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K081052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2008 |
| Decision Date | June 18, 2008 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DYG - Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |