K150257 is an FDA 510(k) clearance for the PreludeEASE Hydrophilic Sheath Introducer. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on June 19, 2015, 136 days after receiving the submission on February 3, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K150257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | February 03, 2015 |
| Decision Date | June 19, 2015 |
| Days to Decision | 136 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 |