Balloon Catheter - India CDSCO Medical Device Registration

Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000710_8ed9cb6bdc14ce1ac902f2894708b919_80ef556f83891b2fbd13aa25ec0880f4. This device is marketed under the brand name pITA. The license holder is Pack Deal, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Balloon Catheter

UID: IMP/MD/2023/000710_8ed9cb6bdc14ce1ac902f2894708b919_80ef556f83891b2fbd13aa25ec0880f4

Brand Name

pITA

License Holder

Pack Deal

Device Class

Class D

Approving Authority

CDSCO

Product Information

pITA is intended for angioplasty of intra- and extracranial brain supplying arteries, harbouring previously untreated stenoses or recurrent stenoses after angioplasty and/or stenting or flow diverter deployment. pITA is also to be used for dilatation of insufficiently adapted stents and flow diverters

Class C

Brand: pITA

Class D

Neurovascular Embolization Device

Brand: Wallaby Avenir Coil System

Class D