ENSITE 3000 SYSTEM— 510(k) K983456

Unknown

Endocardial Solutions, Inc.

FDA 510(k) clearance K983456 for ENSITE 3000 SYSTEM, Unknown on 1999-04-21. Applicant: Endocardial Solutions, Inc..

Clearance details

Applicant: Endocardial Solutions, Inc.
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 1998-09-30
Decision date: 1999-04-21
Decision: Unknown
Clearance type: Traditional
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.