Cook Zenith Low Profile AAA Endovascular Graft System

Singapore - English - HSA (Health Sciences Authority)

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Available from:
COOK SOUTH EAST ASIA PTE LTD
Class:
Class D medical device
Manufactured by:
Cook Medical Incorporated
Therapeutic area:
Cardiovascular
Therapeutic indications:
The Zenith Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including: • Iliac/femoral anatomy that is suitable for access with a 16 French (6.0mm OD) introduction system; • Non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: o with a length of at least 15mm o with a diameter measured outer wall to outer wall of no greater than 28mm and no less than 18mm o with an angle less than 60 degrees relative to the long axis of the aneurysm, and o with an angle less than 45 degrees relative to the axis of the suprarenal aorta • Iliac artery distal fixation site greater than 10mm in length and 8 to 20mm in diameter (measured outer wall to outer wall).
Product summary:
Device System Info:[System or Procedure Pack], [Sterile Medical Device], EO sterilisation; Models: Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-22-70, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-22-84, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-22-98, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-22-108, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-22-118, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-22-128, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-24-70, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-24-84, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-24-98, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-24-108, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-24-118, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-24-128, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-26-70, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-26-84, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-26-98, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-26-108, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-26-118, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-26-128, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-28-70, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-28-84, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-28-98, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-28-108, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-28-118, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-28-128, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-30-70, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-30-84, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-30-98, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-30-108, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-30-118, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-30-128, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-32-70, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-32-84, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-32-98, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-32-108, Zenith Low Profile AAA Endovascular Graft Main Body - ZALB-32-118, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALB-32-128, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-10-36, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-10-48, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-10-60, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-10-72, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-10-84, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-10-96, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-10-108, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-10-120, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-12-36, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-12-48, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-12-60, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-12-72, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-12-84, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-12-96, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-12-108, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-12-120, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-14-36, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-14-48, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-14-60, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-14-72, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-14-84, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-14-96, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-14-108, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-16-36, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-16-48, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-16-60, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-16-72, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-16-84, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-16-96, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-18-36, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-18-48, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-18-60, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-18-72, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-18-84, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-18-96, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-20-36, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-20-48, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-20-60, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-20-72, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-20-84, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-20-96, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-22-36, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-22-48, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-22-60, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-22-72, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-22-84, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-22-96, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-24-36, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-24-48, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-24-60, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-24-72, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-24-84, Zenith Low Profile AAA Endovascular Graft Iliac Leg - ZALL-24-96, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-22-45, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-22-58, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-24-45, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-24-58, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-26-45, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-26-58, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-28-45, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-28-58, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-30-45, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-30-58, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-32-45, Zenith Low Profile AAA Endovascular Graft Body Extension - ZLBE-32-58, Zenith Low Profile AAA Endovascular Graft Converter - ZLC-24-66, Zenith Low Profile AAA Endovascular Graft Converter - ZLC-28-66, Zenith Low Profile AAA Endovascular Graft Converter - ZLC-32-66
Authorization number:
DE0008907
Authorization date:
2012-03-20

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