The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Pursue Microcatheter.
| Device ID | K173548 |
| 510k Number | K173548 |
| Device Name: | Merit Pursue Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Niloufar Samimi |
| Correspondent | Niloufar Samimi Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-16 |
| Decision Date | 2018-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450358747 | K173548 | 000 |
| 10884450358501 | K173548 | 000 |
| 10884450358495 | K173548 | 000 |
| 10884450358525 | K173548 | 000 |
| 10884450358532 | K173548 | 000 |
| 10884450358549 | K173548 | 000 |
| 10884450358556 | K173548 | 000 |
| 10884450358563 | K173548 | 000 |
| 10884450358662 | K173548 | 000 |
| 10884450358679 | K173548 | 000 |
| 10884450358686 | K173548 | 000 |
| 10884450358716 | K173548 | 000 |
| 10884450358723 | K173548 | 000 |
| 10884450358730 | K173548 | 000 |
| 10884450358488 | K173548 | 000 |