VENA CAVA FILTER— 510(k) K073528

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K073528 for VENA CAVA FILTER, Substantially Equivalent on 2008-02-27. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2007-12-17
Decision date: 2008-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, 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.