PTCA Balloon Dilatation Catheter - India CDSCO Medical Device Registration
PTCA Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000224_b63ed5b2326b395b2530b22689ba4551_1f15ce90cf71bdb785d3860e0ce6af63. This device is marketed under the brand name IKAZUCHI Zero, Raiden 3. The license holder is Hester Diagnostics Pvt. Ltd., ,Office No. 213/214/214 A/215/216, Jolly Bhavan No. 1, 2nd Floor, 10, New Marine Lines, Taluka Marine Line, District Mumbai Zone1 ,Mumbai City Maharashtra ,400020 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
IKAZUCHI Zero, Raiden 3
Device Class
Approving Authority
CDSCO
Product Information
This product is intended to be used for dilating the stenosis lesion in the coronary artery when performing percutaneous transluminal coronary angioplasty (IKAZUCHI Zero, Raiden 3).

