Gunther Tulip Vena Cava Filter Retrieval Set— 510(k) K222254

Name: FDA 510(k) clearance K222254
Creator: U.S. Food and Drug Administration
Published: 2023-05-16

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K222254 for Gunther Tulip Vena Cava Filter Retrieval Set, Substantially Equivalent on 2023-05-16. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code MMX
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2022-07-27
Decision date: 2023-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MMX

product code MMX

Death: 3
Total: 3

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.