Guiding Sheath - India CDSCO Medical Device Registration

Guiding Sheath is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000598_1b97e721e419e8744f553c875974319f_de85bd8890658ad8a740b8d38659ac39. This device is marketed under the brand name LifeStream Balloon Expandable Vascular Covered Stent. 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

Guiding Sheath

UID: IMP/MD/2021/000598_1b97e721e419e8744f553c875974319f_de85bd8890658ad8a740b8d38659ac39

Brand Name

LifeStream Balloon Expandable Vascular Covered Stent

License Holder

Becton Dickinson India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Halo One™ Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One™ Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature or the coronary vasculature.