The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Hydrophilic Guide Wire.
| Device ID | K120644 |
| 510k Number | K120644 |
| Device Name: | MERIT HYDROPHILIC GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE Ei |
| Contact | Mark Mullaney |
| Correspondent | Mark Mullaney MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE Ei |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-02 |
| Decision Date | 2012-09-19 |
| Summary: | summary |