PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER— 510(k) K113584

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K113584 for PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER, Substantially Equivalent on 2012-03-02. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 2011-12-05
Decision date: 2012-03-02
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.