Vena Cava Filters - India CDSCO Medical Device Registration

Vena Cava Filters is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000014_d836b6d3a7008b95d9f7bd69be685f5c_6ed5ac4fb904241098d8d774d293a500. This device is marketed under the brand name CROSSER CTO Recanalization Catheter. The license holder is Bard India Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Vena Cava Filters

UID: IMP/MD/2018/000014_d836b6d3a7008b95d9f7bd69be685f5c_6ed5ac4fb904241098d8d774d293a500

Brand Name

CROSSER CTO Recanalization Catheter

License Holder

Bard India Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Denali Filter is Indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations: • Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy for thromboembolic disease • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced • Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated