CLA-2 RR:TC:MM 959752 JAS
Port Director of Customs
10 Causeway Street
Boston, MA 02222-1059
RE: PRD 0401-96-100324; FemoStop, Femoral Compression System; Hemostasis, Apparatus for Stopping Flow or Circulation of Blood in the Femoral Artery; Medical Apparatus Used t o Control Bleeding After Surgery; Hemostatic Kit, Pump, Compression Arch, Mesh Fabric Belt, Plastic Connective Tubing; Sphygmomanometer, Medical Apparatus for Measuring Blood Pressure, Principal Use, Class or Kind, Additional U.S. Rule of Interpretation 1(a); Hartz Mountain Corp. v. United States; Chapter 90, Note 2
Dear Port Director:
This is our decision on Protest 0401-96-100324, filed
against your classification under the Harmonized Tariff Schedule
of the United States (HTSUS), of a femoral compression system or
FemoStop. The entries under protest were liquidated on May 3 and
10 and on June 21, 1996, and this protest timely filed on July 2,
1996. Counsel for the protestant made an additional submission
on May 13, 1997, the contents of which were presented orally at a
meeting in our office on May 15, 1997.
FACTS:
The FemoStop consists of four (4) components designed to
achieve the controlled stoppage, under pressure, of blood flow at
a surgical incision: a pump, consisting of a single hand-held
manometer and rubber inflatable bulb, compression arch, a metal
and plastic device incorporating an inflatable disc or dome,
plastic tubing with a special ferrule at one end and a cut-off
valve at the other end, and mesh fabric belt cut to the same
width as the ends of the arch. In operation, the dome of the
compression arch is placed over the puncture site and secured by
the belt. The plastic tubing connects the pump to the arch and
the pump is used to inflate the dome from 20-30 mmHg (millimeters - 2 -
of mercury) gradually to 60-80 mmHg until the bleeding subsides.
After holding compression for routine duration, pressure is
reduced gradually in increments of 10-20 mmHg every 2-3 minutes
until the bleeding stops. The compression arch, plastic tubing
and fabric belt are packaged together and are disposable after
one use, while the pump is separately packaged and is used
repeatedly. Shipments of the FemoStop pump will always include
the disposable components. However, because more of the
disposable components are required, some shipments will include
only these components.
The merchandise was entered under a provision in heading
9018 for syringes, needles, catheters, cannulae and the like, and
parts and accessories thereof. Your office determined that the
articles comprising the FemoStop are marketed and used to stem
the flow of blood from the femoral artery, a process called
hemostasis. You liquidated the entries under a provision of
heading 9018 as other medical and surgical instruments and
appliances and parts and accessories thereof. Counsel for the
protestant now maintains that notwithstanding its use in a
femoral compression system, the pump component of the FemoStop
belongs to the class or kind of instruments and appliances
principally used in the United States to measure blood pressure.
As such, it is classifiable as a sphygmomanometer, in subheading
9018.90.50, HTSUS, and the other three components are similarly
classified as parts and accessories thereof.
The provisions under consideration are as follows:
9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus...; parts and accessories thereof:
9018.90 Other instruments and appliances and parts
and accessories thereof:
9018.90.50 Sphygmomanometers, tensimeters and oscillometers; all the foregoing and parts and accessories thereof
9018.90.80 Other
- 3 -
ISSUE:
Whether the pump component of the FemoStop is of that class
or kind of medical instruments or appliances principally used to
measure blood pressure.
LAW AND ANALYSIS:
Merchandise is classifiable under the Harmonized Tariff
Schedule of the United States (HTSUS) in accordance with the
General Rules of Interpretation (GRIs). GRI 1 states in part
that for legal purposes, classification shall be determined
according to the terms of the headings and any relative section
or chapter notes, and provided the headings or notes do not
require otherwise, according to GRIs 2 through 6. Chapter 90,
Note 2(b), HTSUS, states in part that parts and accessories are
to be classified with the machines, instruments or apparatus with
which they are solely or principally used.
Protestant maintains that the FemoStop pump is in fact a
sphygmomanometer, an instrument for measuring blood pressure, and
that the plastic tubing, mesh elastic belt and compression arch
are parts and accessories thereof. The claim is that
notwithstanding that the pump is used in the United States as a
component of the FemoStop system, it is of the same quality and
physical construction, and functions with the same certified
precision as a hand aneroid sphyygmomanometer. Protestant
concludes that the FemoStop pump is within the class or kind of
instruments or apparatus principally used to measure blood
pressure and, therefore, is classifiable in subheading
9018.90.50, HTSUS.
At the international level, the provisions of heading 9018
are governed by use. Moreover, we agree that in accordance with
Additional U.S. Rule 1(a), HTSUS, applied at the subheading
9018.90.50 level, it is the principal use of the class or kind of
merchandise to which the FemoStop pump belongs that controls.
Though that subheading designates three particular medical
appliances eo nomine, by name, the criteria of use must be
applied to determined whether the FemoStop pump is encompassed by
any of the named appliances. In order to determine whether an
article falls within a particular class or kind, the Court of
International Trade has sanctioned use of factors such as: (1)
the use, if any, in the same manner as merchandise which defines
the class; (2) the expectations of the purchasers of the
merchandise; (3) the channels of trade in which the merchandise
moves; (4) the environment of the sale of the merchandise, i.e., - 4 -
the accompanying accessories and the manner in which the
merchandise is advertised and displayed; and (5) the physical
appearance of the merchandise, when pertinent. Hartz Mountain
Corp. v. United States, Slip Op. 95-154 (Ct. Int'l Trade, decided
September 1, 1995). The FemoStop pump in issue here is the
Speidel & Keller (S&K) Primus 50. In this case, while a
purchaser of the FemoStop System would expect to use its
components, to include the pump, to effect hemostasis, the Primus
50 is depicted in different parts of the same S&K catalog among
recognized medical instruments designated as sphygmomanometers.
More significantly, the manometer portion of both products
consists of a metal-encased mechanism with dial running 0-300
mmHg, marked in identical 2mm increments, and labeled at 20 mm
intervals. Both products are certified as to calibration ñ 3 mm
accuracy over the full range, and both products have metal stems
for connection to plastic or rubber tubing, a screw-type air
release valve, metal spoon, and a black rubber bulb. In summary,
though the Primus 50 is used in the FemoStop System as a pump to
inflate and hold pressure in the compression arch, its physical
characteristics make it virtually indistinguishable from medical
appliances known as sphygmomanometers. Therefore, the available
evidence warrants the conclusion that the FemoStop pump and
sphygmomanometers belong to the same class or kind of medical
instruments and appliances, the principal use of which is to
measure blood pressure.
HOLDING:
Under the authority of GRI 1, the pump component of the
FemoStop System, designated the Primus 50, is provided for in
heading 9018. It is classifiable in subheading 9018.90.50,
HTSUS. From their design and use, the compression arch, plastic
tubing and mesh fabric belt qualify as parts and accessories
principally used with the pump. Noting Chapter 90, Note 2(b),
these articles are similarly classifiable.
The protest should be ALLOWED. In accordance with Section
3A(11)(b) of Customs Directive 099 3550-065, dated August 4,
1993, Subject: Revised Protest Directive, you should mail this
decision, together with the Customs Form 19, to the protestant no
later than 60 days from the date of this letter. Any
reliquidation of the entry or entries in accordance with the
decision must be accomplished prior to mailing the decision.
Sixty days from the date of the decision the Office of
Regulations and Rulings will take steps to make the decision - 5 -
available to Customs personnel via the Customs Rulings Module in
ACS and to the public via the Diskette Subscription Service, the
Freedom of Information Act and other public access channels.
Sincerely,
John Durant, Director
Tariff Classification
Appeals Division