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/2018/000012_143ce9bec80854c7b4b2f3e6498256ba_21a2de3dd5b2188b00466d9b993045bb. This device is marketed under the brand name SOLACE. The license holder is Biorad Medisys Pvt Ltd, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class D

Balloon Hydrophilic Catheter-PTCA and PTA

UID: MFG/MD/2018/000012_143ce9bec80854c7b4b2f3e6498256ba_21a2de3dd5b2188b00466d9b993045bb

Brand Name

SOLACE

License Holder

Biorad Medisys Pvt Ltd

Device Class

Class D

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

Class D

Brand: Morcellator

Class B