FDA 510(k) Applications Submitted by Phuong Chau

FDA 510(k) Number Submission Date Device Name Applicant
K150107 01/20/2015 Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR
K180238 01/29/2018 CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT Biosense Webster, Inc.
K191660 06/21/2019 CARTO 3 EP Navigation System, Version 7.1 and Accessories Biosense Webster, Inc.
K153071 10/22/2015 Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K173977 12/29/2017 CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module Biosense Webster, Inc.
K173978 12/29/2017 CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module Biosense Webster, Inc.


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