Catheter - India CDSCO Medical Device Registration

Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000192_5513d03dcf1e33d1e561f487a535dd4f_a864cab866b4d7beb385e9bccb430a30. This device is marketed under the brand name Agilis EPI. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Catheter

UID: IMP/MD/2018/000192_5513d03dcf1e33d1e561f487a535dd4f_a864cab866b4d7beb385e9bccb430a30

Brand Name

Agilis EPI

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

• The 4mm Livewire™ TC Catheter is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator set to deliver up to 50 Watts for creating endocardial focal or linear lesions during cardiac ablation procedures to treat arrhythmias. • The 8mm Livewire™ TC Catheter is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator set to deliver up to 100 Watts for treatment of Type I atrial flutter

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