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Cook Five Lumen Central Venous Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032274

by Cook, Inc.

Identifiers

510(k) Number
K032274 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A five lumen central venous catheter is a medical device designed for percutaneous vascular access procedures. It is intended for continuous or intermittent drug infusions, central venous blood pressure monitoring (CVP), acute hyperalimentation, blood sampling, delivery of whole blood or blood products, and simultaneous separate infusion of drugs for multi-lumen catheters.

The device is supplied as a set or tray and is intended for use in percutaneous vascular access procedures. It is manufactured by Cook, Inc. and has received FDA 510(k) clearance under k-number K032274 with product code FOZ. The device is not described as sterile, single-use, reusable, MRI safe, or having specific storage requirements in the provided data.

Frequently asked questions

What is the COOK FIVE LUMEN CENTRAL VENOUS CATHETER used for?

It is intended for percutaneous vascular access procedures, including continuous or intermittent drug infusions, central venous blood pressure monitoring (CVP), acute hyperalimentation, blood sampling, delivery of whole blood or blood products, and simultaneous separate infusion of drugs through its five lumens.

How is the COOK FIVE LUMEN CENTRAL VENOUS CATHETER supplied?

The device is supplied as a set or tray, containing all necessary components for percutaneous vascular access procedures, as manufactured by Cook, Inc.

Is the COOK FIVE LUMEN CENTRAL VENOUS CATHETER sterile or single-use?

The provided data does not specify whether the device is sterile, single-use, or reusable; no information on sterility or use duration is included in the device description or authorization details.

What regulatory pathway was used for the COOK FIVE LUMEN CENTRAL VENOUS CATHETER?

The device received FDA 510(k) clearance under k-number K032274, with a traditional clearance type and a substantially equivalent decision, as indicated by the decision code SESE and product code FOZ.

Are there any specific storage requirements for the COOK FIVE LUMEN CENTRAL VENOUS CATHETER?

The provided data does not mention any specific storage requirements for the device; no storage conditions are described in the specifications or authorization fields.

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: Cook Unimpregnated Central Venous Catheter Set and Tray, Cook Spectrum® Central Venous Catheter Set and Tray, Cook Inc. 5-Lumen Central Venous Catheter Sets - 5-Lumen Central Venous ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cook, Inc.

Sources (1)

  • FDA 510(k) K032274 24 fields · synced Sep 22, 2026