CLA-2 CO:R:C:M 953545 LTO
Mr. David P. Lang
Novacon Corporation
2514 7th Avenue, E.
Suite 11
St. Paul, Minnesota 55109
RE: Balloon Shaft for drug infusion balloon catheter; medical
instruments and appliances; NY 882361; EN 90.18; GRI 2(a)
Dear Mr. Lang:
This is in response to your letter of March 1, 1993,
requesting reconsideration of NY 882361, dated February 24, 1993,
which concerned the classification of a balloon shaft, which is a
part of a "Drug Infusion Balloon Catheter," under the Harmonized
Tariff Schedule of the United States (HTSUS).
FACTS:
The article in question is a balloon shaft, which is a part
of a drug infusion balloon catheter. After importation, a three-
way stopcock, extension tubing and luer connecter are assembled
to the balloon shaft to form a complete drug infusion balloon
catheter. The drug infusion balloon catheter is connected to an
indwelling catheter.
The balloon catheter is used primarily by home patients who
are required to take daily dosages of a physician prescribed drug
(i.e., anti-biotics, chemotherapy, analgesics). It is attached
to an extension tube which is then connected to an indwelling
catheter. The medical preparation to be administered is
introduced into the top opening of the shaft. The preparation
fills and inflates the balloon, and is then gradually fed to the
patient by pressure from the balloon. The rate of flow is
regulated by the stopcock and the type of balloon used.
The submitted sample measures 3 3/4 inches in overall - 2 -
length. It consists of a shaft with an opening and hinged cap at
one end, a balloon covering the middle section, and a Luer-Lok
connection at the other end.
In NY 882361, the article in question was held to be
classifiable under subheading 9018.90.80, HTSUS, which provides
for other instruments and appliances used in medical, surgical,
dental or veterinary sciences.
ISSUE:
Whether the drug infusion balloon catheter is classifiable
as other instruments and appliances used in medical, surgical,
dental or veterinary sciences under subheading 9018.90.80, HTSUS.
LAW AND ANALYSIS:
The General Rules of Interpretation (GRI's) to the HTSUS
govern the classification of goods in the tariff schedule. GRI 1
states in pertinent part that "for legal purposes, classification
shall be determined according to the terms of the headings and
any relative section or chapter notes . . . ." You have asked us
to reconsider the classification of the articles in question
under subheading 9018.90.80, HTSUS, which provides for other
instruments and appliances used in medical sciences, and parts
thereof.
The Harmonized Commodity Description and Coding System
Explanatory Notes (EN) constitute the Customs Co-operation
Council's official interpretation of the Harmonized System.
While not legally binding, the ENs provide a commentary on the
scope of each heading of the Harmonized System, and are generally
indicative of the proper interpretation of these headings.
EN 90.18, pg. 1487, states that heading 9018, HTSUS, "covers
a very wide range of instruments and appliances which, in the
vast majority of cases, are used only in professional practice
(e.g., by doctors, surgeons, dentists, veterinary surgeons,
midwives), either to make a diagnosis, to prevent or treat an
illness or to operate, etc." The notes, pgs. 1488-9, indicate
that the heading includes the following instruments and
appliances for human medicine or surgery: needles; lancets;
trocars; surgical knives and scalpels; sounds; specula; mirrors
and reflectors; scissors; shears; forceps; pliers; chisels;
gouges; mallets; hammers; saws; scrappers; cannulae; catheters;
suction tubes; cauteries; tweezers; dressing, swab, sponge or
needle holders; retractors; dilators; clips; and syringes.
The fact that, as imported, the article in question is not
complete, functional or saleable does not control its - 3 -
classification. First, heading 9018, HTSUS, covers both parts
and accessories for medical instruments and appliances. Second,
GRI 2(a) states that "[a]ny reference in a heading to an article
shall be taken to include a reference to that article incomplete
or unfinished, provided that, as entered, the incomplete or
unfinished article has the essential character of the complete or
finished article."
Accordingly, if the balloon shafts have the essential
character of the complete drug infusion balloon catheter, they
are classifiable under subheading 9018.90.80, HTSUS, as other
medical instruments and appliances. If the balloon shafts do not
have the essential character of the complete article, they would
remain classifiable under subheading 9018.90.80, HTSUS, as a part
for other medical instruments and appliances.
Because the importation in question does not consist of the
portion of the drug infusion balloon catheter that provides the
connection to the patient, nor does it consist of the catheter's
regulating mechanism, the balloon shaft does not have the
essential character of the complete article. Therefore, the
article in question is classifiable as a part of other medical
instruments and appliances.
HOLDING:
The balloon shaft for the drug infusion balloon catheter is
classifiable under subheading 9018.90.80, HTSUS, which provides
for other instruments and appliances used in medical, surgical,
dental or veterinary sciences, and parts thereof. The
corresponding rate of duty for articles of this subheading is
7.9% ad valorem.
NY 882361, dated February 24, 1993, is affirmed.
Sincerely,
John Durant, Director