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 | K201595 |
| 510k Number | K201595 |
| Device Name: | Merit Hydrophilic Guide Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Merit Medical Systems, Inc. Parkmore Business Park West Galway, IE H91 W274 |
| Contact | Mark Mullaney |
| Correspondent | Michael O'sullivan Merit Medical Systems, Inc. Parkmore Business Park West Galway, IE H91 W274 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-12 |
| Decision Date | 2020-10-14 |