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/2019/000509_8ec71e6c6e644aff0c756686847b3c21_bfc89df83dcc8300f85e44c28d9c0df5. This device is marketed under the brand name FAST TRACK, HIGH TRACK, VAS TRACK. The license holder is ORIENT MEDICAL DISTRIBUTORS, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
FAST TRACK, HIGH TRACK, VAS TRACK
License Holder
ORIENT MEDICAL DISTRIBUTORSDevice Class
Approving Authority
CDSCO
Product Information
The PTCA Balloon Catheters are intended for use in the routine treatment of luminal obstruction or residual stenosis in coronary arteries, Guide Wire(FAST TRACK, HIGH TRACK, VAS TRACK)-The Accex Guide Wire is used to facilitate the placement of devices during diagnostic and interventional procedures. The guide wires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures, where increased support, distal flexibility and low surface friction of the guide wire is needed
