Cleared Traditional

Gunther Tulip Vena Cava Filter Retrieval Set

K222254 · Cook Incorporated · Cardiovascular
May 2023
Decision
293d
Days
Class 2
Risk

About This 510(k) Submission

K222254 is an FDA 510(k) clearance for the Gunther Tulip Vena Cava Filter Retrieval Set, 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 review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K222254 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MMX — Device, Percutaneous Retrieval
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150