Cleared Special

ReVive PV (Peripheral Vasculature) Thrombectomy Device

K132281 · Codman & Shurtleff, Inc. · Cardiovascular

Aug 2013

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K132281 is an FDA 510(k) clearance for the ReVive PV (Peripheral Vasculature) Thrombectomy Device, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on August 30, 2013, 38 days after receiving the submission on July 23, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K132281 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	QEW — Peripheral Mechanical Thrombectomy With Aspiration
Device Class	Class II — 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.