K162097 is an FDA 510(k) clearance for the InTRAkit. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on November 17, 2016, 111 days after receiving the submission on July 29, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K162097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2016 |
| Decision Date | November 17, 2016 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |