Drug Coated PTA Balloon Catheter - India CDSCO Medical Device Registration

Drug Coated PTA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000086_fde39f7441100c36998f5164b0f2ad18_3949f8fb036a1dc62df65ddc35da3360. 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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CDSCO Registered

Class Class C

Drug Coated PTA Balloon Catheter

UID: MFG/MD/2020/000086_fde39f7441100c36998f5164b0f2ad18_3949f8fb036a1dc62df65ddc35da3360

Brand Name

Expanse sheath/ Guide sheath/ Large path

License Holder

Relisys Medical Devices Limited

Device Class

Class C

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

The Drug-coated PTA Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (Expanse sheath/ Guide sheath/ Large path) of stenosis or occlusion lesions in iliac, femoral or popliteal arteries