K131446 is an FDA 510(k) clearance for the INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES. This device is classified as a Cannula, Catheter (Class II - Special Controls, product code DQR).
Submitted by Integra LifeSciences Corporation (York, US). The FDA issued a Cleared decision on October 28, 2013, 161 days after receiving the submission on May 20, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1300.
| 510(k) Number | K131446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2013 |
| Decision Date | October 28, 2013 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQR — Cannula, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1300 |