VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER— 510(k) K010485

Substantially Equivalent

Bbraun

FDA 510(k) clearance K010485 for VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER, Substantially Equivalent on 2001-05-18. Applicant: Bbraun.

Clearance details

Applicant: Bbraun
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2001-02-20
Decision date: 2001-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Evanston, IL, US

Download summary PDF View on FDA.gov ↗

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.