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Balloon Hydrophilic Catheter-PTCA and PTA - India CDSCO Medical Device Registration

Balloon Hydrophilic Catheter-PTCA and PTA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000310_e47414a4bcf65f6d7c3d7e0d5f1b2fb4_c285c5245fc9013f5cfb32947c45ab5e. This device is marketed under the brand name Venus. The license holder is Biorad Medisys Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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.

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CDSCO Registered
Class Class C
Balloon Hydrophilic Catheter-PTCA and PTA
UID: MFG/MD/2022/000310_e47414a4bcf65f6d7c3d7e0d5f1b2fb4_c285c5245fc9013f5cfb32947c45ab5e

Brand Name

Venus

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

PTCA: The PTCA catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery including in-stent restenosis, post stent dilatation, or bypass graft for the purpose of improving myocardial perfusion. PTA: The PTA Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents and self- expanding stents.

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