ENSITE 3000 SYSTEM— 510(k) K992479

Unknown

Endocardial Solutions, Inc.

FDA 510(k) clearance K992479 for ENSITE 3000 SYSTEM, Unknown on 1999-12-02. Applicant: Endocardial Solutions, Inc..

Clearance details

Applicant: Endocardial Solutions, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 1999-07-26
Decision date: 1999-12-02
Decision: Unknown
Clearance type: Traditional
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.