Balloon Expandable Cobalt Chromium Renal & Biliary Stent System - India CDSCO Medical Device Registration
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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Brand Name
EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
License Holder
Nano Therapeutics Pvt. Ltd.Device Class
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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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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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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Balloon Expandable Cobalt Chromium Peripheral Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
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Versatile Atrial Septal Occluder Device
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
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Stainless Steel Coronary Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Nano Therapeutics Pvt. Ltd.
Sirolimus Eluting Coronary Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Sirolimus Eluting Coronary Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Versatile Atrial Septal Occluder Delivery System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Cobalt Chromium Mesh Cover Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Everolimus Eluting Coronary Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Everolimus Eluting Coronary Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Paclitaxel Coated Balloon Catheter
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Balloon Expandable Cobalt Chromium Peripheral Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Versatile Atrial Septal Occluder Device
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
Stainless Steel Coronary Stent System
Brand: EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL