Balloon Hydrophilic Catheter-PTCA and PTA
- UID
- MFG/MD/2022/000341_e47414a4bcf65f6d7c3d7e0d5f1b2fb4_7f3b5bdbb1d2bdd446eb77168390ef7a
- Device class
- Class D
- Brand name
- ACE
- License holder
- Biorad Medisys Pvt Ltd
- 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.
Balloon Hydrophilic Catheter-PTCA and PTA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000341_e47414a4bcf65f6d7c3d7e0d5f1b2fb4_7f3b5bdbb1d2bdd446eb77168390ef7a. This device is marketed under the brand name ACE. 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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