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Venous Return Cannulae

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250937

by LivaNova USA, Inc.

Identifiers

510(k) Number
K250937 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)

The Venous Return Cannulae V152-32 is a vascular cannula designed for cardiopulmonary bypass procedures. It facilitates the return of venous blood from the patient’s circulatory system to the extracorporeal circuit, ensuring efficient oxygenation and perfusion during cardiac surgery. Constructed with a bullet tip and suture ring, it provides secure placement and stability within the venous system. The device is reinforced with wire-reinforced tubing to maintain structural integrity during use.

These cannulae are single-use, sterile devices intended for adult cardiopulmonary applications and are classified under FDA 510(k) clearance (K250937). Supplied in sizes such as 32 Fr, they are regulated under 21 CFR 870.4210 and must be used in controlled clinical environments. Compatibility with MRI settings is not specified, and proper disposal follows single-use medical device protocols. Authorized for use in cardiopulmonary bypass systems, they require adherence to sterile technique and manufacturer guidelines for storage and handling.

Frequently asked questions

What is the Venous Return Cannulae V152-32 used for?

The Venous Return Cannulae V152-32 is designed specifically for cardiopulmonary bypass (CPB) procedures. It facilitates the return of venous blood from the patient’s circulatory system to the extracorporeal circuit, ensuring efficient oxygenation and perfusion during cardiac surgery. Its reinforced structure and secure bullet tip help maintain stability within the venous system during use.

How is the Venous Return Cannulae V152-32 supplied and what size is available?

This cannula is supplied as a single-use, sterile device. The primary size available is 32 French (Fr), which is suitable for adult cardiopulmonary applications. Each unit is packaged individually to maintain sterility until use.

Is the Venous Return Cannulae V152-32 reusable or single-use?

The Venous Return Cannulae V152-32 is explicitly designed for single-use only. This ensures patient safety by eliminating the risk of contamination or degradation from repeated sterilization processes. After use, it must be disposed of according to standard single-use medical device protocols.

What materials are used in the construction of the Venous Return Cannulae V152-32?

The cannula features wire-reinforced tubing, which provides structural integrity during CPB procedures. The bullet tip and suture ring are included to enhance secure placement and stability within the venous system. The reinforcement helps prevent kinking or collapse during use.

What storage and handling guidelines should be followed for the Venous Return Cannulae V152-32?

The device must be stored in its original, unopened packaging to preserve sterility. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, verify the packaging is intact and the expiration date has not passed. Always follow manufacturer guidelines for sterile technique during handling and insertion.

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: Adult Venous Return Cannula - LivaNova US, Single Stage Venous Return Cannulae for Adults | LivaNova US, K250937 - Venous Return Cannulae | FDA 510 (k), Venous Return Cannulae (K250937) — FDA 510 (k) | Innolitics, LivaNova USA, Inc. FDA 510 (k) Products - Latest 2026

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
LivaNova USA, Inc.

Sources (1)

  • FDA 510(k) K250937 24 fields · synced Oct 1, 2026