CDSCO UID MFG/MD/2020/000236_02ef5af70feba4ac90cbd7b40bcc7cba_1b9c7e7d4bfad8559ac15d89982d88e9
Balloon Expandable Cobalt Chromium Renal & Biliary Stent System
Nano Therapeutics Pvt. Ltd.·Device Class Class D·India CDSCO·Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Registration details
- UID
- MFG/MD/2020/000236_02ef5af70feba4ac90cbd7b40bcc7cba_1b9c7e7d4bfad8559ac15d89982d88e9
- Device class
- Class D
- Brand name
- EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
- License holder
- Nano Therapeutics Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- The Balloon Expandable Cobalt Chromium Renal Stent System is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL) of a de novo or restenotic atherosclerotic lesion (EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0mm to 8.0mm. Sub-optimal PTRA is defined as ≥ 50% residual stenosis, ≥ 20mmHg peak systolic or ≥ 10mmHg mean translesional pressure gradient, flow-limiting dissection, or TIMI [Thrombolysis In Myocardial Infarction] flow < 3. The Balloon Expandable Cobalt Chromium Biliary Stent System is intended for palpitation of malignant strictures in the biliary tree
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Products from the same license holder (10 products)
Sirolimus Eluting Coronary Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
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Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
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Versatile Atrial Septal Occluder Delivery System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
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Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
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Everolimus Eluting Coronary Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
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Everolimus Eluting Coronary Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
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Paclitaxel Coated Balloon Catheter
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
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About this record
Balloon Expandable Cobalt Chromium Renal & Biliary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000236_02ef5af70feba4ac90cbd7b40bcc7cba_1b9c7e7d4bfad8559ac15d89982d88e9. This device is marketed under the brand name EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL. The license holder is Nano Therapeutics Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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