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Catheter, Angioplasty, Balloon Dilatation - India CDSCO Medical Device Registration

Catheter, Angioplasty, Balloon Dilatation is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000129_bf85d322222f04bec9f79cbad06d0aac_bb18cfc80cc31af7b1cc0272a17d9994. This device is marketed under the brand name XXL Esophageal Balloon Dilatation Catheter. The license holder is Boston Scientific India Pvt. Ltd.,, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Catheter, Angioplasty, Balloon Dilatation
UID: IMP/MD/2018/000129_bf85d322222f04bec9f79cbad06d0aac_bb18cfc80cc31af7b1cc0272a17d9994

Brand Name

XXL Esophageal Balloon Dilatation Catheter

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Peripheral Cutting Balloon Device is indicated for Percutaneous Transluminal Angioplasty (XXL Esophageal Balloon Dilatation Catheter) of obstructive lesions in peripheral vessels. The target lesion should possess the following characteristics: minimal tortuosity of proximal vessel segment, and be a non-angulated lesion segment (XXL Esophageal Balloon Dilatation Catheter)

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