Cleared Traditional

BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM

K072666 · Bio Compression Systems, Inc. · Cardiovascular
Nov 2007
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K072666 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. (Broadview Heights, US). The FDA issued a Cleared decision on November 5, 2007, 45 days after receiving the submission on September 21, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K072666 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2007
Decision Date November 05, 2007
Days to Decision 45 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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