510(k) K161287— DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak

Unknown

Medtronic Vascular

Clearance details

Applicant: Medtronic Vascular
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2016-05-09
Decision date: 2016-08-19
Decision: Unknown
Clearance type: Traditional
Location: Danvers, MA, US

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.