The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude Pursuit Splittable Sheath Introducer.
| Device ID | K172117 |
| 510k Number | K172117 |
| Device Name: | Prelude Pursuit Splittable Sheath Introducer |
| Classification | Introducer, Catheter |
| Applicant | Merit Medical Systems, Inc. 65 Great Valley Parkway Malvern, PA 19355 |
| Contact | Jacquelyn Huyghue |
| Correspondent | Jacquelyn Huyghue Merit Medical Systems, Inc. 65 Great Valley Parkway Malvern, PA 19355 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-13 |
| Decision Date | 2017-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450313883 | K172117 | 000 |
| 10884450313319 | K172117 | 000 |
| 10884450313548 | K172117 | 000 |
| 10884450313845 | K172117 | 000 |
| 10884450313494 | K172117 | 000 |
| 10884450313630 | K172117 | 000 |
| 10884450313616 | K172117 | 000 |
| 10884450313500 | K172117 | 000 |
| 00884450510162 | K172117 | 000 |
| 00884450510292 | K172117 | 000 |
| 00884450510636 | K172117 | 000 |
| 00884450510193 | K172117 | 000 |
| 00884450510612 | K172117 | 000 |
| 10884450313326 | K172117 | 000 |
| 10884450313388 | K172117 | 000 |
| 10884450313517 | K172117 | 000 |
| 10884450313487 | K172117 | 000 |
| 10884450313470 | K172117 | 000 |
| 10884450313449 | K172117 | 000 |
| 10884450313425 | K172117 | 000 |
| 10884450313401 | K172117 | 000 |
| 10884450313647 | K172117 | 000 |
| 10884450313463 | K172117 | 000 |
| 10884450313456 | K172117 | 000 |
| 10884450313432 | K172117 | 000 |
| 10884450313418 | K172117 | 000 |
| 10884450313395 | K172117 | 000 |
| 00884450510735 | K172117 | 000 |