VENA CAVA FILTER SYSTEMS, MODIFICATION— 510(k) K925679

Substantially Equivalent

B. Braun Vena-Tech

FDA 510(k) clearance K925679 for VENA CAVA FILTER SYSTEMS, MODIFICATION, Substantially Equivalent on 1992-11-27. Applicant: B. Braun Vena-Tech.

Clearance details

Applicant: B. Braun Vena-Tech
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 1992-11-10
Decision date: 1992-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Evanston, IL, US

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Adverse events under product code DTK

product code DTK

Death: 208
Injury: 11,286
Malfunction: 3,002
Total: 14,496

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.