GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET— 510(k) K032426

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K032426 for GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET, Substantially Equivalent on 2003-10-31. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2003-08-06
Decision date: 2003-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, 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.