The following data is part of a premarket notification filed by Merit Medical Systems Inc. with the FDA for S-mak Xl.
| Device ID | K190175 |
| 510k Number | K190175 |
| Device Name: | S-MAK XL |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | Merit Medical Systems Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | David Thomas |
| Correspondent | David Thomas Merit Medical Systems Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450410438 | K190175 | 000 |