Balloon Hydrophilic Catheter-PTCA and PTA - India CDSCO Medical Device Registration
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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Brand Name
ACE
License Holder
Biorad Medisys Pvt LtdDevice Class
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.
PTCA Guidewire
Brand: ACE
Biorad Medisys Pvt Ltd
Balloon Hydrophilic Catheter-PTCA and PTA
Brand: Venus
Biorad Medisys Pvt Ltd
Foley Catheter/ Suprapubic/ Cysto Cath
Brand: ACE
Biorad Medisys Pvt Ltd
Co-axial Dilator/Catheter / Suprapubic, Non-Disposable Cannula
Brand: ACE
Biorad Medisys Pvt Ltd
URETHRAL DILATOR/ SUPRAPUBIC, NON-DISPOSABLE CANNULA
Brand: ACE
Biorad Medisys Pvt Ltd
DUAL LUMEN CATHETER
Brand: ACE
Biorad Medisys Pvt Ltd
PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE CATHETER
Brand: ACE
Biorad Medisys Pvt Ltd
URETERAL DILATOR & SET/ SUPRAPUBIC, NON-DISPOSABLE CANNULA
Brand: ACE
Biorad Medisys Pvt Ltd
MALECOT CATHETER / NEPHROSTOMY CATHETER
Brand: ACE
Biorad Medisys Pvt Ltd
MEATAL DILATOR/ SUPRAPUBIC, NON-DISPOSABLE CANNULA
Brand: ACE
Biorad Medisys Pvt Ltd
Stone Basket
Brand: Morcellator
Sheath - B-Sheath /Guiding Sheath/Vessel Dilator for percutaneous Catheterization
Brand: Morcellator
Co-axial Dilator/Catheter / Suprapubic, Non-Disposable Cannula
Brand: Morcellator
Nottingham One Step Catheter / Vessel Dialator for percutaneous Catheterization
Brand: Morcellator
URETHRAL CATHETER
Brand: Morcellator
Amplatz Sheath & Amplatz Dilator
Brand: Morcellator
S-curve Urethral Dilator/ Set
Brand: Morcellator
PCN Catheter/ Kit / Nephrostomy Catheter
Brand: Morcellator
Pathfinder/ Irrigation Pump
Brand: Morcellator
Ureteral Stent
Brand: Morcellator