Cleared Traditional

K222254 - Gunther Tulip Vena Cava Filter Retrieval Set (FDA 510(k) Clearance)

K222254 · Cook Incorporated · Cardiovascular device

May 2023

Decision

293d

Days

Class 2

Risk

K222254 is an FDA 510(k) clearance for the Gunther Tulip Vena Cava Filter Retrieval Set. This device is classified as a Device, Percutaneous Retrieval (Class II - Special Controls, product code MMX).

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 16, 2023, 293 days after receiving the submission on July 27, 2022.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K222254 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 27, 2022
Decision Date	May 16, 2023
Days to Decision	293 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF