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FDA 510(k) Applications Submitted by Nikita Basandra
FDA 510(k) Number
Submission Date
Device Name
Applicant
K220109
01/13/2022
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems Inc.
K173527
11/14/2017
Digitex Delivery Device
Coloplast A/S
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