PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300— 510(k) K131452

Substantially Equivalent

St. Jude Medical Systems AB

FDA 510(k) clearance K131452 for PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300, Substantially Equivalent on 2013-09-05. Applicant: St. Jude Medical Systems AB.

Clearance details

Applicant: St. Jude Medical Systems AB
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 2013-05-20
Decision date: 2013-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westford, MA, 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.