Gianturco-Roehm Birds Nest Vena Cava Filter— 510(k) K161218

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K161218 for Gianturco-Roehm Birds Nest Vena Cava Filter, Substantially Equivalent on 2016-07-22. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2016-04-29
Decision date: 2016-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
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.