The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Preludeease Hydrophilic Sheath Introducer.
| Device ID | K150257 |
| 510k Number | K150257 |
| Device Name: | PreludeEASE Hydrophilic Sheath Introducer |
| Classification | Introducer, Catheter |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Michaela Rivkowich |
| Correspondent | Michaela Rivkowich Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-03 |
| Decision Date | 2015-06-19 |
| Summary: | summary |