Hemostasis Valve - India CDSCO Medical Device Registration

Hemostasis Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000438_9d27c06a33bf5561501cb21dd0d2b15d_91c6197c10dadd23f85cf24f6fed5cb1. This device is marketed under the brand name Guardian® II hemostasis valve and Guardian® II NC hemostasis valve. The license holder is Teleflex Medical Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Hemostasis Valve

UID: IMP/MD/2019/000438_9d27c06a33bf5561501cb21dd0d2b15d_91c6197c10dadd23f85cf24f6fed5cb1

Brand Name

Guardian® II hemostasis valve and Guardian® II NC hemostasis valve

License Holder

Teleflex Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (Guardian® II hemostasis valve and Guardian® II NC hemostasis valve) during diagnostic/interventional procedures. The torque device is provided as an aid for steering the guidewire within the vascular anatomy. The sidearm extension tubing included is provided to extend the sidearm of the Guardian II or Guardian II NC hemostasis valve.