Vascular Closure Device - India CDSCO Medical Device Registration

Vascular Closure Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000169_d8a9f2c0acdaf9986be4febe664de503_29695a6f2b3432096d462644a896e176. This device is marketed under the brand name PVA. The license holder is Agrosurg Irradiators (India) Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class D

Vascular Closure Device

UID: MFG/MD/2019/000169_d8a9f2c0acdaf9986be4febe664de503_29695a6f2b3432096d462644a896e176

Brand Name

PVA

License Holder

Agrosurg Irradiators (India) Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

The Obtura - Vascular Closure Device is indicated for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional catheterization procedures using a standard 6F or 7F introducer sheath with 6F Obtura - Vascular Closure Device and 8F or 9F introducer sheath with 8F Obtura - Vascular Closure Device.