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NY J87713




August 25, 2003

CLA-2-90:RR:NC:N1:105 J87713

CATEGORY: CLASSIFICATION

TARIFF NO.: 9018.39.00

Mr. Paul O’Leary
3 The Lawn, Broadale, Douglas
Cork, Ireland

RE: The tariff classification of an angiographic catheter and tubing from Ireland

Dear Mr. O’Leary:

In your letter dated July 14, 2003, for TFX Medical Ireland Limited, you requested a tariff classification ruling. Samples were provided.

You state regarding the finished angiographic catheter, catalog no. 31-501, which is in an individual sealed package and which is about three feet long with specialized connectors/probes at both ends:

Product Family: Angiographic Catheters

“Angiographic catheters are use to diagnose problems in the vascular system or major organs. Angiographic catheters are introduced into the body using an introducer, the usual point of entry is the femoral artery (top of leg) or brachial artery (elbow). The catheter is manoeuvred to the point in question through the blood stream. To see it there is a problem in the blood supply a die (iodine solution) is injected into the body, which can be seen under X-Ray. Any blockages in blood flow can be easily seen. Catheters are also used to check the workings of the heart and are even deployed inside the chambers of the heart.

Finished Catheters

TFX manufactures a range of sterile catheters in different configurations (length, size and shape). These are sold directly to Medical device OEM’s who then sell them on to hospitals.

The catheter consists of a connector (hub), braided shaft, extruded tube and soft tip. The catheter is made by first joining the soft tip to the extruded tip. The soft tip is made from a very soft material to stop it damaging the blood vessels. This is the part that goes furthest into the body. The tip and extruded tube are melted together at very precise temperatures and time to ensure the strictest tolerances are held (+0.001”). This subassembly is joined by heat to the braided shaft. This again has to have tight controlled and is depended on the materials used in each component. This sub-assembly is now called the bonded-shaft and is “over moulded” with the connector. This catheter sub-assembly can now be shaped (choice of over 50) before packaging. The shape of the catheter is depended on where in the body the product has to reach.”

The applicable subheading for the angiographic catheter will be 9018.39.00, Harmonized Tariff Schedule of the United States (HTS), which provides for catheters, cannulae and the like, and parts and accessories thereof. The rate of duty will be free.

The other items are sold to companies to companies which “manufacture components or sub-assemblies of catheters to customer specs.”

Regarding them, we are returning your request for a classification ruling, and any related samples, exhibits, etc., because we need additional information in order to issue a ruling. Please submit the additional information indicated below:

Is the component identified as the “bonded tube” imported in its finished length?

You state that the bonded tube needs a connector and “shape” to form a complete catheter. Is the “shape” a separate component that is bonded to the bonded tube in order to form a catheter, or is the “shape” formed by heating and then shaping the end of the bonded tube?

Based on your very abbreviated description of the manufacturing process, it appears that the components labeled “soft tip” “extruded tip” and “braided tubing” must be cut after importation and bonded together to form the bonded tube. If this is correct, please confirm. If this is not correct, please explain the manufacturing process in more depth.

It is our understanding that the components labeled “soft tip” and “extruded tip” are made of plastics with additives, but do not contain metal or textile reinforcement. Please confirm.

The component identified as “braided tube” does not appear to be hollow. However, to function as a catheter it must allow the passage of liquid or gas. Please specify whether this component is hollow. Does it function to allow the passage of matter or is it used as a guide wire? What is the component material of the wire?

When this information is available, you may wish to consider resubmission of your request. If you decide to resubmit your request, please include all of the material that we have returned to you and mail your request to U.S. Customs, Customs Information Exchange, 10th Floor, One Penn Plaza, New York, NY 10119, attn: Binding Rulings Section

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the above, contact National Import Specialist J. Sheridan at 646-733-3012.

Sincerely,

Robert B. Swierupski
Director,

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