MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION— 510(k) K070052

Substantially Equivalent

Vilex, Inc.

FDA 510(k) clearance K070052 for MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION, Substantially Equivalent on 2007-03-28. Applicant: Vilex, Inc..

Clearance details

Applicant: Vilex, Inc.
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2007-01-04
Decision date: 2007-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hills, PA, US

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Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.