Coronary Balloon Dilatation Catheter - India CDSCO Medical Device Registration

Coronary Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000134_70bb0cf67d60550b024a8e8a5cfc0545_ba85e57ad13c992f6e7a1c77ea2f588c. This device is marketed under the brand name Wedge Scoring Balloon Dilatation Catheter. The license holder is Rukman Medical Devices And Equipments Pvt Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Coronary Balloon Dilatation Catheter

UID: IMP/MD/2019/000134_70bb0cf67d60550b024a8e8a5cfc0545_ba85e57ad13c992f6e7a1c77ea2f588c

Brand Name

Wedge Scoring Balloon Dilatation Catheter

License Holder

Rukman Medical Devices And Equipments Pvt Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Balloon dilatation of a stent after implantation (Wedge Scoring Balloon Dilatation Catheter)