COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS— 510(k) K121057

Clearance details

Applicant

William Cook Europe Aps

Product code

Code DTK

Device class

Class 2

Regulation

21 CFR 870.3375

Advisory panel

Cardiovascular

Date received

2012-04-06

Decision date

2012-05-04

Decision

Substantially Equivalent

Clearance type

Special

Location

West Lafayette, IN, US

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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 →