PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST— 510(k) K932921

Substantially Equivalent

B. Braun Vena-Tech

FDA 510(k) clearance K932921 for PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST, Substantially Equivalent on 1993-08-30. Applicant: B. Braun Vena-Tech.

Clearance details

Applicant: B. Braun Vena-Tech
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 1993-06-15
Decision date: 1993-08-30
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.