HSA · registration DE0009151Cook Zenith Spiral-Z AAA Iliac Leg with Z-Trak Introduction System
- Registration number
- DE0009151
- Model name
- Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg; Zenith Spiral-Z AAA Iliac Leg
- Model identifier
- ZSLE-11-107-ZT; ZSLE-11-122-ZT; ZSLE-11-39-ZT; ZSLE-11-56-ZT; ZSLE-11-74-ZT; ZSLE-11-90-ZT; ZSLE-13-107-ZT; ZSLE-13-122-ZT; ZSLE-13-39-ZT; ZSLE-13-56-ZT; ZSLE-13-74-ZT; ZSLE-13-90-ZT; ZSLE-16-39-ZT; ZSLE-16-56-ZT; ZSLE-16-74-ZT; ZSLE-16-90-ZT; ZSLE-20-39-ZT; ZSLE-20-56-ZT; ZSLE-20-74-ZT; ZSLE-20-90-ZT; ZSLE-24-39-ZT; ZSLE-24-56-ZT; ZSLE-24-74-ZT; ZSLE-24-90-ZT; ZSLE-9-107-ZT; ZSLE-9-122-ZT; ZSLE-9-39-ZT; ZSLE-9-56-ZT; ZSLE-9-74-ZT; ZSLE-9-90-ZT
- Registration date
- May 04, 2012
- Risk class
- Class D
- Product owner
- Cook Medical Incorporated
- Registrant / registration holder
- COOK SOUTH EAST ASIA PTE LTD
The Zenith Spiral-Z AAA Iliac Leg with the Z-Trak Introduction System is indicated for use with the Zenith AAA Endovascular Graft family of products, including the Zenith Flex AAA Endovascular Graft, Zenith Renu Ancillary Graft, Zenith Fenestrated AAA Endovascular Graft, or Zenith Branch Iliac Endovascular Graft, during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems.
- Product owner address
- 1025 Acuff Road,, P.O. Box 4195, Bloomington, IN 47402-4195, United States
- Registrant address
- 38 BEACH ROAD, #29-11, SOUTH BEACH TOWER, Singapore 189767
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.