Reshapable Guidewire - India CDSCO Medical Device Registration
Reshapable Guidewire is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000114_14a336d10e8a86c423c2f2976ddb1836_8884da50ed01572836ae7509b7960168. This device is marketed under the brand name ASAP Aspiration Catheter Kit and ASAPLP Low Profile Aspiration Catheter Kit. The license holder is M/s Merit Medical Systems India Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
ASAP Aspiration Catheter Kit and ASAPLP Low Profile Aspiration Catheter Kit
License Holder
M/s Merit Medical Systems India Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
The True Form Reshapable Guide Wire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures. The True Form Reshapable Guide Wire should not be used in the neurovasculature.
Manifolds
Brand: Angiographic Tray
Customized Kits - 1(Merit Customs Kit - 1 )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Customized Kits - 2(Merit Customs Kit - 2
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Aspiration Catheters
Brand: ASAP Aspiration Catheter Kit and ASAPLP Low Profile Aspiration Catheter Kit
Needles
Brand: Angiographic Tray
Inflation Devices and Kits(Basix Touch, Basix Compak )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Customized Kits - 3(Merit Customs Kit - 3 )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Custom Manifold Kit
Brand: Angiographic Tray
Sheath Introducer
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Microcatheter
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices