The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude Sheath Introducer.
| Device ID | K070159 |
| 510k Number | K070159 |
| Device Name: | PRELUDE SHEATH INTRODUCER |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Jerrie Hendrickson |
| Correspondent | Jerrie Hendrickson MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-17 |
| Decision Date | 2007-06-21 |
| Summary: | summary |