The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude And Prelude Pro Sheath Introducers.
| Device ID | K073035 |
| 510k Number | K073035 |
| Device Name: | PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Shirley Hyink |
| Correspondent | Shirley Hyink 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 | 2007-10-29 |
| Decision Date | 2007-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450054342 | K073035 | 000 |
| 10884450015299 | K073035 | 000 |
| 20884450331112 | K073035 | 000 |