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 | K170933 |
| 510k Number | K170933 |
| Device Name: | Merit Hydrophilic Guide Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Merit Medical Systems, Inc. Parkmore Business Park West Galway, IE |
| Contact | Mark Mullaney |
| Correspondent | Michael O’sullivan Merit Medical Systems, Inc. Parkmore Business Park West Galway, IE |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-29 |
| Decision Date | 2017-06-22 |
| Summary: | summary |