FDA 510(k) Applications Submitted by THOMAS HIRTE

FDA 510(k) Number Submission Date Device Name Applicant
K180068 01/09/2018 ORISE Gel Boston Scientific
K050304 02/08/2005 FX WIRE ADVANCED MEASUREMENT GUIDEWIRE CONMED CORP.
K140630 03/11/2014 WALLFLEX BILIARY RX STENT SYSTEM BOSTON SCIENTIFIC
K031186 04/15/2003 LUMINEXX ENDOSCOPIC BILIARY STENT C.R. BARD, INC.
K141584 06/13/2014 ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM Boston Scientific Corporation
K171809 06/19/2017 Epic Biliary Endoscopic Stent System Boston Scientific Corporation
K963064 08/07/1996 ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM LABORIE MEDICAL TECH CORP.
DEN150040 08/28/2015 WallFlex Biliary RX Fully Covered Stent System RMV BOSTON SCIENTIFIC
K122660 08/31/2012 RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 Boston Scientific Corporation
K112543 09/01/2011 WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM Boston Scientific Corporation
K173400 10/31/2017 ORISE Tissue Retractor System Boston Scientific
K033562 11/12/2003 FASTRAC GASTRIC ACCESS PORT KIT C.R. BARD, INC.


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