Cleared Traditional

K160593 - Indy OTW Vascular Retriever

K160593 is an FDA 510(k) clearance for Indy OTW Vascular Retriever, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K160593 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K160593

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.

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 23
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
Bard Snare Retrieval Kit
K152560 · Neometrics, Inc. · Oct 2015
EN Snare Endovascular Snare System
K151497 · Merit Medical Systems, Inc. · Jul 2015