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FDA 510(k) Applications Submitted by Priscila Tapia
FDA 510(k) Number
Submission Date
Device Name
Applicant
K221020
04/06/2022
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F
Potrero Medical, Inc.
K152181
08/04/2015
Turbo-Power Laser Atherectomy Catheter
SPECTRANETICS, INC.
K162561
09/14/2016
Turbo-Power (2.0mm) Laser Atherectomy Catheters
SPECTRANETICS, INC.
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