ENSTYLET MODELS EC0010, EC0020— 510(k) K993376

Substantially Equivalent

Endocardial Solutions, Inc.

FDA 510(k) clearance K993376 for ENSTYLET MODELS EC0010, EC0020, Substantially Equivalent on 2000-01-05. Applicant: Endocardial Solutions, Inc..

Clearance details

Applicant: Endocardial Solutions, Inc.
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 1999-10-07
Decision date: 2000-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

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.