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PTCA Balloon Catheter - India CDSCO Medical Device Registration

PTCA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000488_35f2171fa613585bd5d0311eff170695_bc10c12b968d9b3964209c1255fe61a1. This device is marketed under the brand name FirehawkTM Rapamycin Target Eluting Coronary Stent. The license holder is Purple MicroPort Cardiovascular Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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 D
PTCA Balloon Catheter
UID: IMP/MD/2020/000488_35f2171fa613585bd5d0311eff170695_bc10c12b968d9b3964209c1255fe61a1

Brand Name

FirehawkTM Rapamycin Target Eluting Coronary Stent

Device Class

Class D

Approving Authority

CDSCO

Product Information

FOXTROTTMNC is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion๏ผ› And Balloon dilatation of a stent after implantation

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