Sizing Balloon(Cocoon Sizing Balloon ) - India CDSCO Medical Device Registration
Sizing Balloon(Cocoon Sizing Balloon ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000533_68a0215d40ffd009dbaa31d5e821f0ea_47a48fc916b614d57f3ebd54104882ef. 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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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
Device Class
Approving Authority
CDSCO
Product Information
It is intended for sizing atrial communication i.e to measure size of the septal defect
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
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
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)
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
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
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
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
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
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
Sizing Balloon(Cocoon Sizing Balloon )
Brand: Sterile
Vascular Concepts Limited
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
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
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)
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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
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
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
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
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