CDSCO UID IMP/MD/2018/000129_add57d2ac29e6d4222a3a2f5d997c260_1d75d7b60caa6f41c9c9e5c194b6d029
Iliac artery stent; Multiple Peripheral artery stent, bare metal; Trachea prosthesis; Bare Metal Biliary stent; Bare Metal Bronchial stent
Boston Scientific India Pvt. Ltd.,·Device Class Class C·India CDSCO·Brand: Hot Axios Stent and Electrocautery-Enhanced Delivery System
Registration details
- UID
- IMP/MD/2018/000129_add57d2ac29e6d4222a3a2f5d997c260_1d75d7b60caa6f41c9c9e5c194b6d029
- Device class
- Class C
- Brand name
- Hot Axios Stent and Electrocautery-Enhanced Delivery System
- License holder
- Boston Scientific India Pvt. Ltd.,
- Approving authority
- CDSCO
- Product information
- Iliac Artery The WALLSTENT-Uni Endoprosthesis is indicated for use following suboptimal percutaneous transluminal angioplasty (Hot Axios Stent and Electrocautery-Enhanced Delivery System) of common and/or external iliac artery stenotic lesions, which are less than or equals to 10 cm in length. A suboptimal PTA is defined as a technically successful dilation, judged by the physician to be suboptimal due to the presence of unfavorable lesion morphology such as: * An inadequate angiographic and/or hemodynamic result as defined by a 30 percentage or greater residual stenosis after PTA, lesion recoil, or intimal flaps. * Flow limiting dissections post PTA longer than the initial lesion length. * A 5 mm Hg or greater mean transtenotic pressure gradient post PTA. Superficial Femoral Artery The WALLSTENT-Uni Endoprosthesis is intended for use in the treatment of superficial femoral artery (Hot Axios Stent and Electrocautery-Enhanced Delivery System) stenoses or occlusions. Transjugular Intrahepatic Portosystemic Shunt (Hot Axios Stent and Electrocautery-Enhanced Delivery System) The WALLSTENT-Uni Endoprosthesis is indicated for creation of transjugular intrahepatic shunt connections between the portal venous system and the hepatic vein for prophylaxis of variceal bleeding or intractable ascites in the treatment of portal hypertension and its complications in patients who have previously failed conventional treatment techniques. Biliary The WALLSTENT-Uni Endoprosthesis is indicated for use in the treatment of biliary strictures produced by malignant neoplasms. Tracheobronchial The WALLSTENT-Uni Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. Central Venous The WALLSTENT-Uni Endoprosthesis is indicated for the treatment of central venous obstruction and for improving central venous luminal diameter following unsuccessful angioplasty in patients on chronic hemodialysis with stenosis of the venous outflow tract. Unsuccessful angioplasty is defined as residual stenosis greater than or equals to 30 percentage for a vein less than or equals to 10 mm in diameter or greater than or equals to 50 percentage for a vein greater than 10 mm in diameter, a tear which interrupts the integrity of the intima lumen, abrupt lesion site occlusion, or refractory spasm. The vessels that can be treated with the WALLSTENT-Uni Endoprosthesis are the innominate and subclavian veins, ranging from 8 mm to 15 mm in diameter. Superior Vena Cava (Hot Axios Stent and Electrocautery-Enhanced Delivery System) The WALLSTENT-Uni Endoprosthesis is intended for use in the palliative treatment of stenosis of the superior vena cava due to a malignant process. Iliac Vein The WALLSTENT-Uni Endoprosthesis is intended for use in the iliac veins for the treatment of symptomatic venous obstruction
Similar products (10)
Other products with the same name or brand
Bare-metal Biliary Stent
Brand: Hot Axios Stent and Electrocautery-Enhanced Delivery System
Boston Scientific India Pvt. Ltd.,
Class C
Bare-metal Colonic stent
Brand: Hot Axios Stent and Electrocautery-Enhanced Delivery System
Boston Scientific India Pvt. Ltd.,
Class C
Polymer-metal Biliary Stent
Brand: Hot Axios Stent and Electrocautery-Enhanced Delivery System
Boston Scientific India Pvt. Ltd.,
Class C
Stent System
Brand: Hot Axios Stent and Electrocautery-Enhanced Delivery System
Boston Scientific India Pvt. Ltd.,
Class C
Iliac artery stent; Multiple Peripheral artery stent, bare metal; Trachea prosthesis; Bare Metal Biliary stent; Bare Metal Bronchial stent
Brand: Wallflex Biliary Transhepatic Partially Covered Stent System
Boston Scientific India Private Limited ,C/o Parekh Integrated Services Pvt.Ltd., 1st Floor, Khasra Nos. 9//12/3 min (3-17), 13/3min (5-7), 18(8-0), 19min (5-16), 22min (5-16), 23(8-0), 13//2min (5-16), 3 (8-0), Village Bhangrola, Sector M-12 ,Gurgaon Haryana ,122505 ,India
Class C
Peripheral angioplasty balloon catheter, basic
Brand: Hot Axios Stent and Electrocautery-Enhanced Delivery System
Boston Scientific India Pvt. Ltd.,
Class C
Bare-metal biliary stent
Brand: Hot Axios Stent and Electrocautery-Enhanced Delivery System
Boston Scientific India Pvt. Ltd.,
Class C
Bare-metal biliary stent
Brand: Hot Axios Stent and Electrocautery-Enhanced Delivery System
Boston Scientific India Pvt. Ltd.,
Class C
Bare-metal biliary stent
Brand: Hot Axios Stent and Electrocautery-Enhanced Delivery System
Boston Scientific India Pvt. Ltd.,
Class C
Multiple peripheral artery stent, bare metal
Brand: Hot Axios Stent and Electrocautery-Enhanced Delivery System
Boston Scientific India Pvt. Ltd.,
Class C
Other products from Boston Scientific India Pvt. Ltd.,
Products from the same license holder (10 products)
Guidewire
Brand: Zipwire Hydrophilic Guidewire
Class B
Artificial Urinary Sphincter
Brand: AMS 800
Class C
Inflatable Penile Prosthesis
Brand: AMS 800
Class C
Lead Extension kit
Brand: 2x8 Contact Lead Extension kit
Class D
Defibrillator lead
Brand: RELIANCE 4 FRONT
Class D
Endocardial Leads
Brand: RELIANCE 4 FRONT
Class D
Endocardial Leads
Brand: RELIANCE 4 FRONT
Class D
Defibrillator lead implantable
Brand: RELIANCE 4 FRONT
Class D
Endocardial Defibrillation lead
Brand: RELIANCE 4 FRONT
Class D
Defibrillator/pacemaker lead
Brand: RELIANCE 4 FRONT
Class D
About this record
Iliac artery stent; Multiple Peripheral artery stent, bare metal; Trachea prosthesis; Bare Metal Biliary stent; Bare Metal Bronchial stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000129_add57d2ac29e6d4222a3a2f5d997c260_1d75d7b60caa6f41c9c9e5c194b6d029. This device is marketed under the brand name Hot Axios Stent and Electrocautery-Enhanced Delivery System. The license holder is Boston Scientific India Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.