Cleared Traditional

K201705 - ReVene Thrombectomy Catheter

K201705 is the FDA 510(k) clearance for ReVene Thrombectomy Catheter by Vetex Medical, Ltd.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K201705 · Vetex Medical, Ltd. · Cardiovascular device
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Dec 2020
Decision
183d
Days
Class 2
Risk

K201705 is an FDA 510(k) clearance for the ReVene Thrombectomy Catheter. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Vetex Medical, Ltd. (Galway, IE). The FDA issued a Cleared decision on December 22, 2020 after a review of 183 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 Vetex Medical, Ltd. devices

Submission Details

510(k) Number K201705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2020
Decision Date December 22, 2020
Days to Decision 183 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
58d slower than avg
Panel avg: 125d · This submission: 183d
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 126
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K201705.
ClotTriever Thrombectomy System
K210190 · Irani Medical, Inc. · Feb 2021
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
K210083 · Penumbra, Inc. · Feb 2021
NeVa PV Thrombectomy Device
K201085 · Vesalio · Jan 2021
CAPERE Thrombectomy System
K203476 · Vascular Medcure, Inc. · Dec 2020
FlowTriever Retrieval/Aspiration System
K202345 · Inari Medical · Dec 2020
Triever20 Curve Catheter
K203333 · Inari Medical, Inc. · Dec 2020