Introducer Sheath Set - India CDSCO Medical Device Registration
Introducer Sheath Set is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000227_577edac583012d2c5040698cb9f55a67_00b0f10ea57fd80c0cac4a770ccfb76b. This device is marketed under the brand name Trans-Intro. The license holder is Translumina Therapeutics LLP, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
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Brand Name
Trans-Intro
License Holder
Translumina Therapeutics LLPDevice Class
Approving Authority
CDSCO -North Zone, Ghaziabad
Product Information
Introducer set for single use is mainly used to penetrate into artery at the beginning of the intervention operation and then introduce the guidewire into the lead blood vessel in the intervention operation. The Introducer Sheath is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Guiding Catheter
Brand: Agile Pro
Angio Kit
Brand: Trans-Needle
Inflation Device
Brand: Trans-ID
Manifold
Brand: Trans-Needle
PTCA Y Connector Kit
Brand: Trans-Needle
Introducer Needle
Brand: Trans-Needle
PTCA Kit
Brand: Trans-Needle
Angiographic/Diagnostic Catheter
Brand: Racer PC
Sirolimus Eluting Coronary Stent System
Brand: Racer PC
Non Compliant PTCA Balloon Catheter
Brand: Racer PC

