Cleared Traditional

K213494 - Aveir Retrieval Catheter

K213494 is an FDA 510(k) clearance for Aveir Retrieval Catheter, manufactured by Abbott Medical. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K213494 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
151d
Days
Class 2
Risk

K213494 is an FDA 510(k) clearance for the Aveir Retrieval Catheter. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Abbott Medical (Sylmar, US). The FDA issued a Cleared decision on April 1, 2022 after a review of 151 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 Abbott Medical devices

FDA 510(k) Submission Details - K213494

510(k) Number K213494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2021
Decision Date April 01, 2022
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMX Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K213494.
Gunther Tulip Vena Cava Filter Retrieval Set
K222254 · Cook Incorporated · May 2023
LimFlow V-Ceiver
K222083 · LimFlow, Inc. · Aug 2022
ONO Retrieval Device
K212988 · Onocor Vascular, LLC · May 2022
Halo Single-Loop Microsnare Kit
K200963 · Argon Medical Devices, Inc. · Jan 2021
Halo™ Single-Loop Snare Kit
K200268 · Argon Medical Devices, Inc. · Jun 2020
Merit ONE Snare System
K193507 · Merit Medical Systems, Inc. · Jan 2020