Cleared Traditional

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

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

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

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 16, 2023 after a review of 293 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Incorporated devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 125d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MMX Device, Percutaneous Retrieval
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MMX Device, Percutaneous Retrieval

All 31
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K222254.
LimFlow V-Ceiver
K242776 · LimFlow, Inc. · Feb 2025
Amplatz Goose Neck Snare Kit
K241259 · Medtronic, Inc. · Jun 2024
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K232443 · Argon Medical Devices, Inc. · Sep 2023
Aveir Retrieval Catheter
K213494 · Abbott Medical · Apr 2022
Halo Single-Loop Microsnare Kit
K200963 · Argon Medical Devices, Inc. · Jan 2021