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CDSCO UID IMP/MD/2020/000533_48fe5c68e995038f500d4fd410b1353a_46d397d8445ca6fbaafaf312c18a8540

Transcatheter Aortic Valve

M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India·Device Class Class D·India CDSCO·Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
Registration details
UID
IMP/MD/2020/000533_48fe5c68e995038f500d4fd410b1353a_46d397d8445ca6fbaafaf312c18a8540
Device class
Class D
Brand name
Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
License holder
M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India
Approving authority
CDSCO
Product information
The Hydra Valve system is indicated for patients with severe degenerative aortic stenosis presenting a high predictable operative mortality risk for surgical aortic valve replacement and therefore is referred to transcatheter aortic valve implantation. The decision is based on the clinical judgment of the Heart Team. The Hydra valve system is indicated for patients with severe degenerative aortic stenosis presenting a high predictable operative mortality risk for surgical aortic valve replacement. The Hydra valve transcatheter aortic valve implantation necessitates valve replacement of the native aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve and presenting with femoral access vessels with diameters ≥ 6 mm and anatomical dimensions of the aortic annulus diameter between 18mm to 27mm
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Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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Delivery System(Cocoon VSD- Delivery System- Cocoon VSD Occluder Accessory Set / Cocoon VSD Occluder Accessory Set II , Cocoon VSD- Delivery System- Cocoon Delivery Cable including Cable Sheath along with Components/ Accessories VSD Sheath, VSD Dilator, Loader, Hemostasis Valve, Cable Sheath)
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Delivery System(Cocoon Septal Delivery System- Cocoon Septal Occluder Accessory Set , Cocoon Duct Delivery System- Cocoon Duct Occluder Accessory Set , Cocoon Delivery Cable along with Components/ Accessories ASD Sheath/ PDA Sheath, ASD Dilator/ PDA Dilator, Loader, Hemostatis Valve)
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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Occluder(Cocoon PFO Occluder )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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Occluder(Cocoon VSD Occluder )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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About this record

Transcatheter Aortic Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000533_48fe5c68e995038f500d4fd410b1353a_46d397d8445ca6fbaafaf312c18a8540. This device is marketed under the brand name Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System. The license holder is M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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