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/2023/000120_8ed9cb6bdc14ce1ac902f2894708b919_80ef556f83891b2fbd13aa25ec0880f4. This device is marketed under the brand name p48 MW. The license holder is Sunrise Imaging Systems, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
p48 MW
License Holder
Sunrise Imaging SystemsDevice Class
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
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