PressureWire X— 510(k) K180558

Substantially Equivalent

St. Jude Medical (Now Part of Abbott Medical)

FDA 510(k) clearance K180558 for PressureWire X, Substantially Equivalent on 2018-03-28. Applicant: St. Jude Medical (Now Part of Abbott Medical).

Clearance details

Applicant: St. Jude Medical (Now Part of Abbott Medical)
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 2018-03-01
Decision date: 2018-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.