Summary for ARTG Entry:
Boston Scientific Pty Ltd - Zurpaz Steerable Sheath - Cardiovascular device introducer, steerable
ARTG entry for
Medical Device Included Class III
Boston Scientific Pty Ltd
PO Box 332,BOTANY, NSW, 1455
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
1. Zurpaz Steerable Sheath - Cardiovascular device introducer, steerable
Single Device Product
57968 Cardiovascular device introducer, steerable
The steerable sheath set is designed to provide flexible catheter positioning in the cardiac anatomy. It is
fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A
sideport with 3-way stopcock is provided for air/blood aspiration, fluid infusion, blood sampling and
pressure monitoring. The handle is equipped with a rotating knob to deflect the tip clockwise ? 180° and
counterclockwise ? 90°.
Indicated for use when introducing various cardiovascular catheters into the heart, including the left side of
the heart through the interatrial septum.
No Specific Conditions included on Record
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