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CDSCO UID IMP/MD/2021/000088_70851186971c0930340b49c9c9121a77_9d88c541d815e1612d2d85c6de4cfa8f

Drug Coated Balloon PTA Catheter

Bard India Healthcare Pvt. Ltd.·Device Class Class C·India CDSCO·Brand: Lutonix 035 Drug Coated Balloon PTA Catheter
Registration details
UID
IMP/MD/2021/000088_70851186971c0930340b49c9c9121a77_9d88c541d815e1612d2d85c6de4cfa8f
Device class
Class C
Brand name
Lutonix 035 Drug Coated Balloon PTA Catheter
License holder
Bard India Healthcare Pvt. Ltd.
Approving authority
CDSCO
Product information
The Lutonix 014 Drug Coated Balloon Catheter is intended for use as a PTA catheter to dilate stenotic or obstructive vascular lesions in the lower extremities, for the purpose of improving limb perfusion and decreasing the incidence of restenosis.
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About this record

Drug Coated Balloon PTA Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000088_70851186971c0930340b49c9c9121a77_9d88c541d815e1612d2d85c6de4cfa8f. This device is marketed under the brand name Lutonix 035 Drug Coated Balloon PTA Catheter. The license holder is Bard India Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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