Kit(Penumbra System-Reperfusion Catheter and Aspiration Tubing ) - India CDSCO Medical Device Registration

Kit(Penumbra System-Reperfusion Catheter and Aspiration Tubing ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000227_e04c541f628ca6302fb6ab3af829948a_139ec55097754f39b1cf5f50b0af0b23. This device is marketed under the brand name Neuron MAX 6F Long Sheath. 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

Kit(Penumbra System-Reperfusion Catheter and Aspiration Tubing )

UID: IMP/MD/2022/000227_e04c541f628ca6302fb6ab3af829948a_139ec55097754f39b1cf5f50b0af0b23

Brand Name

Neuron MAX 6F Long Sheath

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 (Neuron MAX 6F Long Sheath) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (Neuron MAX 6F Long Sheath) or who fail IV t-PA therapy are candidates for treatment. As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump