Inqwire Diagnostic Guide Wire— 510(k) K170700

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K170700 for Inqwire Diagnostic Guide Wire, Substantially Equivalent on 2017-04-06. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2017-03-07
Decision date: 2017-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.