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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 43 Results
ProductCode: DQY Applicant: BOSTON SCIENTIFIC Decision Date To: 11/27/2021
 
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watchman fxd curve access system Boston Scientific Corporation K212228 08/13/2021
mamba and mamba flex microcatheters Boston Scientific Corporation K190401 03/15/2019
watchman truseal access system Boston Scientific K180864 07/20/2018
mamba and mamba flex microcatheters Boston Scientific Corporation K171452 08/21/2017
rubicon 14, 18 and 35 support catheters Boston Scientific Corporation K171913 07/25/2017
acuity pro lead delivery system Boston Scientific Corporation K171612 06/30/2017
guidezilla ii guide extension catheter; guidezilla ii long guide extension catheter Boston Scientific Corporation K163314 03/23/2017
coyote monorail percutaneous transluminal angioplasty balloon dilatation catheter, express sd biliary monorail premounted stent system, maverick xl percutaneous transluminal coronary angioplasty monorail dilatation catheter, sterling monorail percutaneous transluminal angioplasty balloon dilatation Boston Scientific Corporation K162350 11/04/2016
stingray lp catheter BOSTON SCIENTIFIC CORPORATION K152401 12/04/2015
acuity pro lead delivery system BOSTON SCIENTIFIC K132914 04/03/2014
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