Revascularization Device - India CDSCO Medical Device Registration
Revascularization Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000208_8e7e0dc6a79258796389636d52125b9b_99d951fa60072c75b1415a59e119cc90. This device is marketed under the brand name Embotrap II. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Embotrap II
License Holder
Johnson & Johnson Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
It is intended to be used to restore blood flow in patients experiencing an acute ischemic stroke due to a large vessel neurovascular occlusion. The device is designed for use in the anterior and posterior neurovasculature in vessels of diameter 1.5mm to 5mm, such as the internal carotid artery, the M1 and M2 segments of the middle cerebral artery, the A1 and A2 segments of the anterior cerebral artery, the basilar, the posterior cerebral and the vertebral arteries. The Device should only be used by physicians trained in neurointerventional catheterization and the treatment of ischemic stroke.
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