K152044 is an FDA 510(k) clearance for the Flexor Radial Hydrophilic Introducer Access Set. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on August 14, 2015, 22 days after receiving the submission on July 23, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K152044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2015 |
| Decision Date | August 14, 2015 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |