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FDA 510(k) Applications Submitted by Kris Miller
FDA 510(k) Number
Submission Date
Device Name
Applicant
K110085
01/11/2011
VANTAGE VIEW SYSTEM
ST. JUDE MEDICAL
K210586
02/26/2021
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
Cardiovascular Systems Inc.
K220568
02/28/2022
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Cardiovascualr Systems Inc.
K150583
03/09/2015
Aequalis PerFORM+ Shoulder System
TORNIER, INC.
K190634
03/12/2019
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems Inc.
K101697
06/16/2010
ENSITE VERISMO SEGMENTATION TOOL V.2.0
ST. JUDE MEDICAL
K132073
07/03/2013
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
ST. JUDE MEDICAL
K182397
09/04/2018
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Cardiovascular Systems Inc.
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