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 | K170700 |
| 510k Number | K170700 |
| Device Name: | Inqwire Diagnostic 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 | 2017-03-07 |
| Decision Date | 2017-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450355968 | K170700 | 000 |
| 10884450239718 | K170700 | 000 |
| 20884450239661 | K170700 | 000 |
| 10884450239503 | K170700 | 000 |
| 10884450239497 | K170700 | 000 |
| 10884450239473 | K170700 | 000 |
| 20884450239463 | K170700 | 000 |
| 20884450239456 | K170700 | 000 |
| 10884450434632 | K170700 | 000 |
| 20884450434622 | K170700 | 000 |
| 20884450239739 | K170700 | 000 |
| 10884450239749 | K170700 | 000 |
| 20884450239753 | K170700 | 000 |
| 20884450355958 | K170700 | 000 |
| 10884450335977 | K170700 | 000 |
| 20884450311510 | K170700 | 000 |
| 20884450311497 | K170700 | 000 |
| 10884450239800 | K170700 | 000 |
| 10884450239794 | K170700 | 000 |
| 10884450239787 | K170700 | 000 |
| 10884450239770 | K170700 | 000 |
| 20884450239760 | K170700 | 000 |
| 20884450434646 | K170700 | 000 |