Transseptal Needles - India CDSCO Medical Device Registration

Transseptal Needles is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000189_532fe19b32d1316c7675dcb4b253832e_39de5917882a2fba001546cbc1c4fc5a. This device is marketed under the brand name BRK Transseptal Needles. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Transseptal Needles

UID: IMP/MD/2018/000189_532fe19b32d1316c7675dcb4b253832e_39de5917882a2fba001546cbc1c4fc5a

Brand Name

BRK Transseptal Needles

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The BRK™ Transseptal Needle is used to puncture the interatrial Septum during a transseptal catheterization. Procedure to gain left heart access.

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