The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude Snap Splittable Sheath Introducer.
| Device ID | K143255 |
| 510k Number | K143255 |
| Device Name: | Prelude SNAP Splittable Sheath Introducer |
| Classification | Introducer, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 65 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Contact | Alina Stubbs |
| Correspondent | Alina Stubbs MERIT MEDICAL SYSTEMS, INC. 65 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-13 |
| Decision Date | 2015-04-09 |
| Summary: | summary |