The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude Sheath Introducer.
| Device ID | K130791 |
| 510k Number | K130791 |
| 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 | Michaela Rivkowich |
| Correspondent | Michaela Rivkowich 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 | 2013-03-22 |
| Decision Date | 2013-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450330696 | K130791 | 000 |
| 20884450009783 | K130791 | 000 |
| 20884450009745 | K130791 | 000 |
| 20884450009738 | K130791 | 000 |
| 20884450009721 | K130791 | 000 |
| 20884450009714 | K130791 | 000 |
| 20884450009660 | K130791 | 000 |
| 20884450009653 | K130791 | 000 |
| 20884450009646 | K130791 | 000 |
| 20884450009639 | K130791 | 000 |
| 20884450009622 | K130791 | 000 |
| 20884450009790 | K130791 | 000 |
| 20884450009806 | K130791 | 000 |
| 20884450010628 | K130791 | 000 |
| 20884450330665 | K130791 | 000 |
| 20884450330641 | K130791 | 000 |
| 20884450330610 | K130791 | 000 |
| 20884450330597 | K130791 | 000 |
| 20884450330573 | K130791 | 000 |
| 20884450330566 | K130791 | 000 |
| 20884450330528 | K130791 | 000 |
| 20884450330504 | K130791 | 000 |
| 20884450330467 | K130791 | 000 |
| 20884450010659 | K130791 | 000 |
| 20884450330481 | K130791 | 000 |