VANTAGE VIEW SYSTEM— 510(k) K110085

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K110085 for VANTAGE VIEW SYSTEM, Substantially Equivalent on 2011-01-26. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 2011-01-11
Decision date: 2011-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.