MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000— 510(k) K012926

Unknown

Endocardial Solutions, Inc.

FDA 510(k) clearance K012926 for MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000, Unknown on 2001-09-28. Applicant: Endocardial Solutions, Inc..

Clearance details

Applicant: Endocardial Solutions, Inc.
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 2001-08-31
Decision date: 2001-09-28
Decision: Unknown
Clearance type: Special
Location: St. Paul, MN, US

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Adverse events under product code MTD

product code MTD

Death: 22
Injury: 376
Malfunction: 986
Total: 1,384

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.