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Better-Tubing

FDA 510(k)

Class II (US FDA 510(k))

510(k) K964205

by Circulatory Technology, Inc.

Identifiers

510(k) Number
K964205 FDA 510(k)
FDA Product Code
DWF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4210 FDA 510(k)
Regulation Number
870.4210 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Better-Tubing is a vascular, cardiopulmonary bypass catheter, cannula, and tubing device. It is designed for use in cardiovascular surgery applications.

This device is regulated under 21 CFR 870.4210 and received FDA 510(k) clearance under K964205. It is manufactured by Circulatory Technology, Inc.

Frequently asked questions

What is the intended use of Better-Tubing?

Better-Tubing is designed for use in cardiovascular surgery applications. It functions as a vascular, cardiopulmonary bypass catheter, cannula, and tubing device.

Is this device regulated by the FDA?

Yes, Better-Tubing is regulated under 21 CFR 870.4210 and received FDA 510(k) clearance under K964205.

Who is the manufacturer of this device?

Better-Tubing is manufactured by Circulatory Technology, Inc., located in Oyster Bay, New York.

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: The Better-Bladder is an inline reservoir providing compliance to ..., Circulatory Technology Inc produces medical devices for cardiovascular ..., BETTER-TUBING 510 (k) K964205 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Circulatory Technology, Inc.

Sources (1)

  • FDA 510(k) K964205 24 fields · synced Sep 27, 2026