Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Micra Introducer - Model MI2355A - Cardiovascular device introducer,
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. Micra Introducer - Model MI2355A - Cardiovascular device introducer, non-steerable
Single Device Product
57941 Cardiovascular device introducer, non-steerable
The Micra introducer is a single-use, disposable, hydrophilically coated sheath that provides a
flexible and hemostatic conduit for the insertion of intravascular devices into the venous system to
minimize blood loss. The system is comprised of 2 components: a dilator that accomodates a guidewire
and an introducer.
The Micra introducer is intended to provide a conduit for the insertion of devices into the venous system
and to minimize blood loss associated with such insertions
Nil variant (as 1 device) N/A
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:38:09 AEDT
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