Cleared Traditional

BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM

K131327 · Bio Compression Systems, Inc. · Cardiovascular
Jul 2013
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K131327 is an FDA 510(k) clearance for the BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Bio Compression Systems, Inc. (Oms River, US). The FDA issued a Cleared decision on July 18, 2013, 71 days after receiving the submission on May 8, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K131327 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2013
Decision Date July 18, 2013
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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