Summary for ARTG Entry:
Culpan Medical Pty Ltd - FRED Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial
ARTG entry for
Medical Device Included Class III
Culpan Medical Pty Ltd
PO Box 114,PYRMONT, NSW, 2009
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.
30 bis rue du Vieil Abreuvoir
Saint-Germain-en-Laye, , 78100
1. FRED Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial
Single Device Product
46352 Stent, vascular, intracranial
A self-expanding nickel titanium, single wire braid, compliant closed cell paired-stent design that can be
simultaneously deployed and retrieved by a single operator. The FRED system features integrated dual
layer coverage designed to focus mainly at the neck of an aneurysm. The FRED system has distal and
proximal markers on its ends as well as interweaved helical marker strands delineating the inner working
length of the stent to provide fluoroscopic visibility.
The FRED system is intended for endovascular embolization of intracranial neurovascular aneurysms. The
FRED system may also be used with embolic coils for the treatment of intracranial neurovascular lesions.
Diameter (mm) 2.5 - 5.5
Product name (see guidance docs) FRED Jr
Length (mm) Total 13 - 45
Length (mm) Working 7 - 39
No Specific Conditions included on Record
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