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_f3b3dd0ff9b58e9220413b2528be591b. 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.
Brand Name
FirehawkTM Rapamycin Target Eluting Coronary Stent
License Holder
Purple MicroPort Cardiovascular Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
FOXTROTTM PRO is indicated for balloon pre-dilatation of the stenotic atherosclerotic lesions in patients with following coronary artery diseases: • Angina pectoris (FirehawkTM Rapamycin Target Eluting Coronary Stent) • Myocardial infarction (FirehawkTM Rapamycin Target Eluting Coronary Stent) • One or more stenosis in one vessel; • Multi-vessel stenosis and distal vessel stenosis • Coronary artery restenosis after coronary artery bypass graft (FirehawkTM Rapamycin Target Eluting Coronary Stent) • Coronary artery re-stenosis after PTCA • Protected left main coronary artery stenosis
PTCA Balloon Catheter
SMT Cardiovascular Pvt. Ltd.
PTCA Balloon Catheter
SMT Cardiovascular Pvt. Ltd.
PTCA Balloon Catheter
Brand: 1. WILMA 2. FINCH & 3.PIPIT
Sahajanand Medical Technologies Limited
PTCA Balloon Catheter
Brand: FlexiTrack SC, FlexiTrack NC
Sahajanand Laser Technology Limited (SLTL)
PTCA Balloon Catheter
Brand: FlexiTrack SC, FlexiTrack NC
Sahajanand Laser Technology Limited (SLTL)
PTCA Balloon Catheter
Brand: 1.Supraflex, 2. Flexilimus, 3. Protolimus, 4. Vactaflex, 5. Supralimus-Flex, 6. Flexilimus Plus, 7. Protolimus Plus, 8. Vactaflex Plus, 9. Supralimus Flex Plus, 10. Aima Plus, 11. Abrax CoCr
Sahajanand Medical Technologies Pvt. Ltd.
PTCA Balloon Catheter
Brand: FlexyStar, Passager, HexaPro, Stepper
Sahajanand Laser Technology Limited
PTCA Balloon Catheter
Brand: Ripper, Vector Pro, Impeller, Waive
Sahajanand Laser Technology Limited (SLTL Medical)
PTCA Balloon Catheter
Brand: SeQuent Neo
B BRAUN MEDICAL INDIA PRIVATE LIMITED
Rapamycin Target Eluting Coronary Stent System
Brand: FirehawkTM Rapamycin Target Eluting Coronary Stent
Purple MicroPort Cardiovascular Private Limited
Rapamycin Target Eluting Coronary Stent System
Brand: FirehawkTM Rapamycin Target Eluting Coronary Stent
Rapamycin Target Eluting Coronary Stent System
Brand: FirehawkTM Rapamycin Target Eluting Coronary Stent
Rapamycin Target Eluting Coronary Stent System
Brand: FirehawkTM Rapamycin Target Eluting Coronary Stent
PTCA Balloon Catheter
Brand: FirehawkTM Rapamycin Target Eluting Coronary Stent
PTCA Balloon Catheter
Brand: FirehawkTM Rapamycin Target Eluting Coronary Stent
PTCA Balloon Catheter
Brand: FirehawkTM Rapamycin Target Eluting Coronary Stent