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Bioarterial Plus Arterial Blood Flow Enhancement System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072666

by Bio Compression Systems, Inc.

Identifiers

510(k) Number
K072666 FDA 510(k)
FDA Product Code
JOW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5800 FDA 510(k)
Regulation Number
870.5800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bioarterial Plus is a compressible limb sleeve system designed to enhance arterial blood flow. It functions as an intermittent, high-pressure, rapid-cycle compression system that sequentially compresses the foot and calf to promote oxygenated blood flow in the legs of patients with arterial disease.

This device is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, including conditions such as intermittent claudication, rest pain, and arteriopathic wounds. The system is identified by model number IC-BAP-DL and is authorized under FDA 510(k) clearance.

Frequently asked questions

What is the primary purpose of the Bioarterial Plus system?

The Bioarterial Plus is designed as an adjunct therapy to enhance arterial blood flow in the legs. It is specifically intended for patients suffering from ischemic disease of the lower extremities, including conditions such as rest pain, intermittent claudication, and arteriopathic wounds.

How does the Bioarterial Plus function?

The device operates as an intermittent, high-pressure, rapid-cycle compression system. It utilizes a compressible limb sleeve to provide sequential compression to the foot and calf, which promotes the flow of oxygenated blood in the legs.

What is the regulatory status of this device?

The Bioarterial Plus, identified by model number IC-BAP-DL, is authorized under FDA 510(k) clearance. It is classified under regulation number 870.5800.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bio Compression Systems BioArterial Plus Manual, IC-BAP-DL - BioCompression Systems, PDF Arterial Blood Flow Enhancement System Operating Instructions

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio Compression Systems, Inc.

Sources (1)

  • FDA 510(k) K072666 24 fields · synced Sep 26, 2026