Neurovascular Stent - India CDSCO Medical Device Registration

Neurovascular Stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000486_3913dc6b8c05895a3dace9b711e83551_573fa0d1fec8779dc2c04fd76cb48465. This device is marketed under the brand name Aperio® Hybrid Thrombectomy Device. The license holder is Morulaa Health Tech 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

Neurovascular Stent

UID: IMP/MD/2019/000486_3913dc6b8c05895a3dace9b711e83551_573fa0d1fec8779dc2c04fd76cb48465

Brand Name

Aperio® Hybrid Thrombectomy Device

License Holder

Morulaa Health Tech Pvt Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

"Used in combination with the NeuroSpeed® PTA Balloon Catheter, the CREDO® Stent is indicated to increase the vessel diameter of intracranial arteries (Aperio® Hybrid Thrombectomy Device) that are suitable for and accessible to the system (Aperio® Hybrid Thrombectomy Device) in patients: • with arteriosclerotic (Aperio® Hybrid Thrombectomy Device) vessel constrictions (Aperio® Hybrid Thrombectomy Device) with significant circulatory disturbance (Aperio® Hybrid Thrombectomy Device), • with recurrent symptoms in spite of antiaggregation therapy (Aperio® Hybrid Thrombectomy Device) after at least two events (Aperio® Hybrid Thrombectomy Device). • aged 18 to 80. • whose last stroke occurred at least 7 days before and in whom the impairment after stroke has a rating of 3 or less on the modified Rankin scale (Aperio® Hybrid Thrombectomy Device) at the time of treatment."