The following data is part of a premarket notification filed by Merit Medical System, Inc. with the FDA for Go2wire Guide Wire.
| Device ID | K193571 |
| 510k Number | K193571 |
| Device Name: | Go2Wire Guide Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Merit Medical System, Inc. Parkmore Business Park West Galway, IE |
| Contact | Mark Mullaney |
| Correspondent | Michael O'sullivan Merit Medical System, Inc. Parkmore Business Park West Galway, IE |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450372238 | K193571 | 000 |
| 20884450397453 | K193571 | 000 |
| 20884450372306 | K193571 | 000 |
| 10884450397449 | K193571 | 000 |
| 10884450372224 | K193571 | 000 |
| 20884450397330 | K193571 | 000 |
| 10884450372101 | K193571 | 000 |
| 20884450372276 | K193571 | 000 |
| 20884450372269 | K193571 | 000 |
| 10884450372293 | K193571 | 000 |
| 20884450397354 | K193571 | 000 |
| 10884450397463 | K193571 | 000 |
| 10884450372248 | K193571 | 000 |
| 10884450372217 | K193571 | 000 |
| 10884450397364 | K193571 | 000 |
| 10884450397425 | K193571 | 000 |
| 10884450397340 | K193571 | 000 |