Revascularization Device
- UID
- IMP/MD/2019/000544_8e7e0dc6a79258796389636d52125b9b_24dddf85ab23740b82ba0e911c39550b
- Device class
- Class D
- Brand name
- Kit
- License holder
- M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.
- Approving authority
- CDSCO
- Product information
- As part of the Penumbra System, the Penumbra 3D Revascularization Device is 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
Revascularization Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000544_8e7e0dc6a79258796389636d52125b9b_24dddf85ab23740b82ba0e911c39550b. 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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