Peripheral Stent System - India CDSCO Medical Device Registration
Peripheral Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000086_2ef8d650c58e699764f154f2102aaf6b_28be77d7f18465b048fdb48626f0db4e. This device is marketed under the brand name Expanse sheath/ Guide sheath/ Large path. The license holder is Relisys Medical Devices Limited, and it is classified as Device Class Class C. The approving authority is CDSCO, Zonal office, Hyderabad.
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Brand Name
Expanse sheath/ Guide sheath/ Large path
License Holder
Relisys Medical Devices LimitedDevice Class
Approving Authority
CDSCO, Zonal office, Hyderabad
Product Information
The Peripheral Stent System is indicated for improving luminal diameter in the treatment of patients with de novo or restenotic native lesion(Expanse sheath/ Guide sheath/ Large path) of the iliac artery, superficial femoral artery and/or proximal popliteal artery with total lesion length up to 150 mm and with a reference vessel diameter ranging from 3 mm to 8 mm. To avoid involvement of the common femoral artery, the most proximal stent end should be placed at least 1 cm below the origin of the superficial femoral artery. To avoid involvement of the below-the-knee popliteal artery, the most distal stent end should be placed above the plane of the femoral epicondyles
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