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/2018/000045_5513d03dcf1e33d1e561f487a535dd4f_820110c93e91e67d7187dbf7bc426721. This device is marketed under the brand name FlexAbility Sensor Enabled Ablation Catheter. 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/2018/000045_5513d03dcf1e33d1e561f487a535dd4f_820110c93e91e67d7187dbf7bc426721

Brand Name

FlexAbility Sensor Enabled Ablation Catheter

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

FlexAbility Sensor Enabled Catheter is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating lesions during cardiac ablation procedures (FlexAbility Sensor Enabled Ablation Catheter) for the treatment of arrhythmias. Sensor Enabled Ablation Catheters are used with compatible magnetic tracking systems to enable catheter positioning and navigation. Epicardial ablation should be limited to appropriately selected patients with ventricular tachycardia.

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