Peripheral Orbital Atherectomy System - India CDSCO Medical Device Registration
Peripheral Orbital Atherectomy System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000668_f7f82ea5ea6b2dd9d9cb818cf1d71659_20a16dcc37360f1f96fc5f419d03825a. This device is marketed under the brand name Diamondback 360. The license holder is Innvolution Healthcare Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Diamondback 360
License Holder
Innvolution Healthcare Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
The Orbital Atherectomy Device (Diamondback 360) is intended for use in the treatment of peripheral arteries stenosis. The Orbital Atherectomy Device uses an electrically driven shaft to apply a diamond coated, eccentrically rotating sanding surface to remove stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body. The Stealth 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy
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