Balloon Dilatation Catheter - India CDSCO Medical Device Registration

Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000064_16eb53f14e746dc332d80db12a830d7a_9043ee92ed55c3c6fc595dd383beeddd. This device is marketed under the brand name Sprinter Legend Rapid Exchange Balloon Dilatation Catheter. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Balloon Dilatation Catheter

UID: IMP/MD/2019/000064_16eb53f14e746dc332d80db12a830d7a_9043ee92ed55c3c6fc595dd383beeddd

Brand Name

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

License Holder

India Medtronic Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The balloon catheter expands the stenotic portion of a coronary artery or bypass graft stenosis during PTCA. Balloon cathetermodels that are 2.25 to 4.00 mm in diameter are also indicated for post-delivery expansion of balloon-expandable stents