Cleared Traditional

Indy OTW Vascular Retriever (K160593) - FDA 510(k) Clearance

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

K160593 · Cook Incorporated · Cardiovascular device
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Sep 2016
Decision
185d
Days
Class 2
Risk

K160593 is an FDA 510(k) clearance for the Indy OTW Vascular Retriever. 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 September 2, 2016 after a review of 185 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 K160593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date September 02, 2016
Days to Decision 185 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
60d slower than avg
Panel avg: 125d · This submission: 185d
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 19
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K160593.
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K191758 · Argon Medical Devices, Inc. · Dec 2019
Günther Tulip® Vena Cava Filter Retrieval Set
K181757 · Cook Incorporated · Nov 2018
Expro Elite Snare, Sympro Elite Snare
K163307 · Vascular Solutions, Inc. · Mar 2017
Recovery Cone Removal System
K152136 · C.R. Bard, Inc. · Feb 2016
EN Snare Endovascular Snare System
K151497 · Merit Medical Systems, Inc. · Jul 2015
ONE Snare Endovascular Microsnare System
K142265 · Merit Medical Systems, Inc. · Nov 2014