K003288 is an FDA 510(k) clearance for the ORIGEN DUAL LUMEN CATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Origen Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on June 8, 2001, 231 days after receiving the submission on October 20, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K003288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2000 |
| Decision Date | June 08, 2001 |
| Days to Decision | 231 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 |