Cleared Special

K132281 - ReVive PV (Peripheral Vasculature) Thrombectomy Device

K132281 is an FDA 510(k) clearance for ReVive PV (Peripheral Vasculature) Thro..., manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Special 510(k) pathway after a 38-day FDA review.

K132281 · Codman & Shurtleff, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K132281

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

QEW Device Classification - Class 2, Special Controls

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 144
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K132281.
Infusion Aspiration Catheter System
K143563 · Inari Medical, Inc. · Feb 2015
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K141617 · Rex Medical, L.P. · Nov 2014
ANGIOJET ULTRA AVX THROMBECTOMY SET
K133629 · Possis Medical, Inc. · Feb 2014
ANGIOJET ULTRA POWER PULSE KIT
K130381 · Medrad, Inc. · Jul 2013
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
K121917 · Penumbra, Inc. · Sep 2012
F.A.S.T. SYSTEM SED AND CXD
K092623 · Genesis Medical Interventional, Inc. · Oct 2009
K132281 · ReVive PV (Peripheral Vasculature) Thrombectomy Device
Download PDF FDA Summary Codman & Shurtleff, I…