VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM— 510(k) K152765

Substantially Equivalent

B. Braun Interventional Systems, Inc.

FDA 510(k) clearance K152765 for VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM, Substantially Equivalent on 2016-02-26. Applicant: B. Braun Interventional Systems, Inc..

Clearance details

Applicant: B. Braun Interventional Systems, Inc.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2015-09-24
Decision date: 2016-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, 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.