Cleared Traditional

CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K141617) - FDA 510(k) Clearance

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

K141617 · Rex Medical, L.P. · Cardiovascular device
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Nov 2014
Decision
150d
Days
Class 2
Risk

K141617 is an FDA 510(k) clearance for the CLEANER ROTATIONAL THROMBECTOMY SYSTEM. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Rex Medical, L.P. (Great Neck, US). The FDA issued a Cleared decision on November 14, 2014 after a review of 150 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 Rex Medical, L.P. devices

Submission Details

510(k) Number K141617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2014
Decision Date November 14, 2014
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.
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 - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 119
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K141617.
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter
K173672 · Inari Medical · Feb 2018
V2K Rinspiration System
K172716 · V2k Medical, Inc. · Jan 2018
ZelanteDVT Thrombectomy Set
K151313 · Boston Scientific Corporation · Sep 2015
ReVive PV (Peripheral Vasculature) Thrombectomy Device
K132281 · Codman & Shurtleff, Inc. · Aug 2013