The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Inqwire Diagnostic Guide Wire.
| Device ID | K163575 |
| 510k Number | K163575 |
| Device Name: | Inqwire Diagnostic Guide Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Merit Medical Systems, Inc. Parkmore Business Park West Galway, IE N-a |
| Contact | Mark Mullaney |
| Correspondent | Michael O’sullivan Merit Medical Systems, Inc. Parkmore Business Park West Galway, IE N-a |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450239701 | K163575 | 000 |
| 10884450239695 | K163575 | 000 |
| 20884450239685 | K163575 | 000 |
| 10884450239671 | K163575 | 000 |