The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude Short Sheath Introducer.
| Device ID | K082063 |
| 510k Number | K082063 |
| Device Name: | PRELUDE SHORT SHEATH INTRODUCER |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-21 |
| Decision Date | 2008-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450123847 | K082063 | 000 |
| 20884450015319 | K082063 | 000 |
| 20884450015326 | K082063 | 000 |
| 20884450015333 | K082063 | 000 |
| 20884450015340 | K082063 | 000 |
| 20884450015357 | K082063 | 000 |
| 20884450015364 | K082063 | 000 |
| 20884450015371 | K082063 | 000 |
| 20884450015388 | K082063 | 000 |
| 20884450015395 | K082063 | 000 |
| 20884450015401 | K082063 | 000 |
| 20884450015418 | K082063 | 000 |
| 20884450123779 | K082063 | 000 |
| 20884450123786 | K082063 | 000 |
| 20884450123809 | K082063 | 000 |
| 20884450015302 | K082063 | 000 |