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CPS Direct Universal Slittable Outer Guide Catheter DS2C029

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231311

by Abbott Medical

Identifiers

510(k) Number
K231311 FDA 510(k)
FDA Product Code
DQY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CPS Direct Universal slittable outer guide catheter is designed for intracardiac access of the venous system of the heart. It serves as a conduit during implantation for the delivery of contrast medium, implantable left heart leads, and other delivery tools, while supporting the flow of fluids where minimizing blood loss is essential.

This device is part of the Abbott Cardiac Positioning System family and is intended to facilitate left heart lead delivery. It has received FDA 510k clearance under K231311. Users should refer to the provided instructions for use for specific handling, storage, and clinical application requirements.

Frequently asked questions

What is the primary clinical purpose of the CPS Direct Universal catheter?

This device is designed to provide intracardiac access to the venous system of the heart. It functions as a conduit to facilitate the delivery of contrast medium, implantable left heart leads, and various delivery tools during implantation procedures.

How does the design of this catheter assist during lead delivery?

The catheter is engineered to support the flow of fluids while minimizing blood loss during the procedure. Its slittable outer guide design is specifically intended to facilitate the delivery of left heart leads as part of the Abbott Cardiac Positioning System.

What is the regulatory status of the CPS Direct Universal catheter?

The CPS Direct Universal slittable outer guide catheter (DS2C029) has received FDA 510k clearance under submission number K231311, where it was determined to be substantially equivalent to existing devices.

Where can I find specific handling and storage requirements for this device?

Users should refer to the provided instructions for use (IFU) that accompany the device. The IFU contains the necessary clinical application requirements, as well as specific guidance on the proper handling and storage of the catheter to ensure it remains suitable for use.

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: PDF SLITTABLE OUTER GUIDE CATHETER CPS Direct Universal 3D, CPS Direct™ Universal slittable outer guide catheter (DS2C029) (K231311 ..., PDF Instructions for Use - manuals.eifu.abbott

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Medical

Sources (1)

  • FDA 510(k) K231311 24 fields · synced Sep 26, 2026