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

Name: FDA 510(k) clearance K113584
Creator: U.S. Food and Drug Administration
Published: 2012-03-02

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. Device class: 2.

Clearance details

Applicant: St Jude Medical
Product code: Code DXO
Device class: Class 2
Regulation: 21 CFR 870.2870
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 ↗

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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.