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/2021/000693_d836b6d3a7008b95d9f7bd69be685f5c_d0c6d25da08d73228b2ac03f9637e23e. This device is marketed under the brand name CROSSER CTO Recanalization Catheter. The license holder is Becton Dickinson India Private Limited, 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/2021/000693_d836b6d3a7008b95d9f7bd69be685f5c_d0c6d25da08d73228b2ac03f9637e23e

Brand Name

CROSSER CTO Recanalization Catheter

License Holder

Becton Dickinson India Private Limited

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 The Denali Filter may be removed according to the instructions supplied under section labeled: “Optional Procedure for Filter Removal”

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Recanalization Catheter

Brand: CROSSER CTO Recanalization Catheter

Becton Dickinson India Private Limited

Vena Cava Filters - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

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