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CDSCO UID IMP/MD/2023/000120_8ed9cb6bdc14ce1ac902f2894708b919_80ef556f83891b2fbd13aa25ec0880f4

Balloon Catheter

Sunrise Imaging Systems·Device Class Class D·India CDSCO·Brand: p48 MW
Registration details
UID
IMP/MD/2023/000120_8ed9cb6bdc14ce1ac902f2894708b919_80ef556f83891b2fbd13aa25ec0880f4
Device class
Class D
Brand name
p48 MW
License holder
Sunrise Imaging Systems
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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Products from the same license holder (10 products)
Neurovascular Embolization Device
Brand: Wallaby Avenir Coil System
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Steerable Hydrophilic Guidewire
Brand: p48 MW
Class D
Thrombectomy Device
Brand: p48 MW
Class D
Microcatheter
Brand: p48 MW
Class D
Flow Modulation Device
Brand: p48 MW
Class D
Flow Modulation Device
Brand: p48 MW
Class D
Bifurcation Aneurysm Implant
Brand: p48 MW
Class D
Neurovascular Embolization Device
Brand: Wallaby Avenir Coil System
Class D
Steerable Hydrophilic Guide Wire
Brand: pFMD
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Thrombectomy Device
Brand: pFMD
Class D
About this record

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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