The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude 7f Short Sheath Introducer.
| Device ID | K122190 |
| 510k Number | K122190 |
| Device Name: | PRELUDE 7F SHORT SHEATH INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton, TX 77515 |
| Contact | Dan Clark |
| Correspondent | Dan Clark MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton, TX 77515 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-24 |
| Decision Date | 2012-08-17 |
| Summary: | summary |