Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Sentrant™ Introducer Sheath with Hydrophilic Coating - Cardiovascular
device introducer, non-steerable
ARTG entry for
Medical Device Included Class III
Medtronic Australasia Pty Ltd
PO Box 945,NORTH RYDE BC, NSW, 1670
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.
710 Medtronic Parkway
Minneapolis, MN, 55432
United States Of America
1. Sentrant™ Introducer Sheath with Hydrophilic Coating - Cardiovascular device introducer, non-steerable
Medical device system
57941 Cardiovascular device introducer, non-steerable
The Sentrant™ introducer sheath is comprised of 2 components: a dilator and an introducer sheath which
accommodate a 0.89mm guidewire. The dilator is radiopaque and has a tapered, flexible tip that facilitates
atraumatic tracking through the vasculature. The introducer sheath is comprised of a hydrophilic,
coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly.
The Sentrant Introducer Sheath is intended to provide a conduit for the insertion of diagnostic or
endovascular devices into the vasculature and to minimise blood loss associated with such insertions.
Guage (French) 12-26
Length (cm) 28-64
No Specific Conditions included on Record
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