Reperfusion Catheter - India CDSCO Medical Device Registration

Reperfusion Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000544_834fe13571ebe8eb3daca8f6844f5952_501b5062d9fab1b425151f8370cda111. This device is marketed under the brand name Kit. The license holder is M/S ASIA ACTUAL INDIA (OPC) 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

Reperfusion Catheter

UID: IMP/MD/2019/000544_834fe13571ebe8eb3daca8f6844f5952_501b5062d9fab1b425151f8370cda111

Brand Name

Kit

License Holder

M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.

Device Class

Class D

Approving Authority

CDSCO

Product Information

As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (Kit) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (Kit) or who fail IV t-PA therapy are candidates for treatment