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Temporary occlusion catheters - India CDSCO Medical Device Registration

Temporary occlusion catheters is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000079_7bbb4ccdc0a34661e4976595c9d9c8c8_ca4dd0186f1dd109e84a4a8517b7d9b6. This device is marketed under the brand name VASCO+. The license holder is Balt India Private Limited ,Shop No. 115,116, A Wing, 119 Business Point Co-op Premises SOC Sahar Road, Near Air cargo Complex, Sahar Village, Andheri East (Mumbai Zone5) ,Mumbai City Maharashtra ,400099 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Temporary occlusion catheters
UID: IMP/MD/2020/000079_7bbb4ccdc0a34661e4976595c9d9c8c8_ca4dd0186f1dd109e84a4a8517b7d9b6

Brand Name

VASCO+

Device Class

Class D

Approving Authority

CDSCO

Product Information

The ECLIPSE 2L and COPERNIC 2L double lumen balloon catheters are intended for use in the peripheral vasculature and neurovasculature for temporary occlusion. The balloon catheters provide temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for the vasospasm treatment. The balloon catheters also offer balloon assisted embolization of intracranial aneurysms. They are also indicated for: Use in the peripheral vasculature and neurovasculature for administration of diagnostic agents (VASCO+) and therapeutic agents (VASCO+)

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