Summary for ARTG Entry:
Penumbra Neuro Australia Pty Ltd - 5MAX Reperfusion Catheter - Embolectomy/thrombectomy suction
ARTG entry for
Medical Device Included Class III
Penumbra Neuro Australia Pty Ltd
Suite 3 Level 5 / 1 Oxford Street,DARLINGHURST, NSW, 2010
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.
One Penumbra Place
Alameda, CA, 94502
United States Of America
1. 5MAX Reperfusion Catheter - Embolectomy/thrombectomy suction catheter
Single Device Product
58173 Embolectomy/thrombectomy suction catheter
The Penumbra System was designed to remove thrombus from large intracranial vessels by aspirating the
proximal side of the thrombus. The Reperfusion Catheter is introduced through a guide catheter or long
femoral sheath and into the intracranial vasculature and guided over a guidewire to the site of the primary
occlusion. The Penumbra Reperfusion Catheter is used in parallel with the Penumbra Separator and an
aspiration source to separate the thrombus and aspirate it from the occluded vessel.
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke
secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral ± M1
and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
Length (cm) 125-132
Shape (of tip) straight
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:58:04 AEDT
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