Cleared Special

ReVive PV (Peripheral Vasculature) Thrombectomy Device (K132281) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K132281 · Codman & Shurtleff, Inc. · Cardiovascular device
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Aug 2013
Decision
38d
Days
Class 2
Risk

K132281 is an FDA 510(k) clearance for the ReVive PV (Peripheral Vasculature) Thrombectomy Device. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on August 30, 2013 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K132281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2013
Decision Date August 30, 2013
Days to Decision 38 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

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 140
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K132281.
INDIGO® Aspiration System – INDIGO Link
K260599 · Penumbra, Inc. · Apr 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · Penumbra, Inc. · Feb 2026
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister
K260028 · Argon Medical Devices, Inc. · Feb 2026
RoVo Mechanical Thrombectomy System
K253730 · Verge Medical, Inc. · Jan 2026
Sangria™ Thrombectomy System
K251207 · Avantec Vascular Corporation · Jan 2026
Helo Thrombectomy System
K252956 · Endovascular Engineering, Inc. · Dec 2025