MODIFICATION TO ENSITE SYSTEM, MODEL EE3000— 510(k) K060954

Substantially Equivalent

St. Jude Medical, Inc.-Endocardial Solutions

FDA 510(k) clearance K060954 for MODIFICATION TO ENSITE SYSTEM, MODEL EE3000, Substantially Equivalent on 2006-04-21. Applicant: St. Jude Medical, Inc.-Endocardial Solutions.

Clearance details

Applicant: St. Jude Medical, Inc.-Endocardial Solutions
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2006-04-07
Decision date: 2006-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.