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CDSCO UID IMP/MD/2020/000533_9787bd614b92c5517fbec81c1f60c3e8_7cd6b5a9523fae2d6586d70cb97d1599

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)

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_9787bd614b92c5517fbec81c1f60c3e8_7cd6b5a9523fae2d6586d70cb97d1599
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
It is intended for placement and if necessary retrieval of the device. Individual functions : 1. A delivery sheath with hemostasis valve adapter used to deliver the device, 2. A dilator used to ease penetration of tissues, 3. A loader used to introduce the device into the delivery sheath, 4. A delivery cable with a supporting sheath, on which the occluder is screwed at its distal tip, that allows for placement and retrieval of the device
Similar products (8)
Other products with the same name or brand
Delivery System(Cocoon PFO- Delivery System- Cocoon PFO- Occluder Accessory Set , Cocoon PFO- Delivery System- Cocoon Delivery Cable along with Components/ Accessories PFO Sheath, PFO Dilator, Loader, Hemostasis 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
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
Class D
Septal Occluder(Cocoon Septal 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
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
Class D
Duct Occluder(Cocoon Duct 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
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
Class D
Sizing Balloon(Cocoon Sizing Balloon )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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
Class D
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
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
Class D
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
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
Class D
Transcatheter Aortic 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
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
Class D
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
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
Class D
Other products from 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
Products from the same license holder (8 products)
Delivery System(Cocoon PFO- Delivery System- Cocoon PFO- Occluder Accessory Set , Cocoon PFO- Delivery System- Cocoon Delivery Cable along with Components/ Accessories PFO Sheath, PFO Dilator, Loader, Hemostasis 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
Class D
Septal Occluder(Cocoon Septal 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
Class D
Duct Occluder(Cocoon Duct 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
Class D
Sizing Balloon(Cocoon Sizing Balloon )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
Class D
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
Class D
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
Class D
Transcatheter Aortic 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
Class D
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
Class D
About this record

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) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000533_9787bd614b92c5517fbec81c1f60c3e8_7cd6b5a9523fae2d6586d70cb97d1599. 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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