The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Hydrophilic Guidewire.
| Device ID | K141295 |
| 510k Number | K141295 |
| Device Name: | MERIT HYDROPHILIC GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE Ireland |
| Contact | Michael O'sullivan |
| Correspondent | Michael O'sullivan MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE Ireland |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-19 |
| Decision Date | 2014-12-16 |
| Summary: | summary |