K113869 is an FDA 510(k) clearance for the ORIGEN REINFORCED DUAL LUMEN CATHETER. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by Origen Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on July 26, 2012, 209 days after receiving the submission on December 30, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K113869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2011 |
| Decision Date | July 26, 2012 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4210 |