CARE-E-VAC 3— 510(k) K062610

Substantially Equivalent

Ohio Medical Corporation

FDA 510(k) clearance K062610 for CARE-E-VAC 3, Substantially Equivalent on 2006-09-28. Applicant: Ohio Medical Corporation.

Clearance details

Applicant: Ohio Medical Corporation
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2006-09-05
Decision date: 2006-09-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Gurnee, IL, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.