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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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CDSCO Registered
Class Class D
PTCA Balloon Dilatation Catheter
UID: IMP/MD/2019/000224_b63ed5b2326b395b2530b22689ba4551_1f15ce90cf71bdb785d3860e0ce6af63

Brand Name

IKAZUCHI Zero, Raiden 3

Device Class

Class D

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).

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Other Products from 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
Products from the same license holder (5 products)