QUANTIEN Measurement System— 510(k) K183099

Substantially Equivalent

St. Jude Medical (Now Abbott Medical)

FDA 510(k) clearance K183099 for QUANTIEN Measurement System, Substantially Equivalent on 2019-02-28. Applicant: St. Jude Medical (Now Abbott Medical).

Clearance details

Applicant: St. Jude Medical (Now Abbott Medical)
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2018-11-07
Decision date: 2019-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.