The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Mak (mini Access Kit) With Palladium Tip Guide Wire.
| Device ID | K091584 |
| 510k Number | K091584 |
| Device Name: | MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Susan Christensen |
| Correspondent | Susan Christensen 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-02 |
| Decision Date | 2009-10-09 |
| Summary: | summary |