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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 46 Results
ProductCode: DQY Applicant: BOSTON SCIENTIFIC Decision Date To: 04/26/2024
 
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watchman trusteer access system (m635tu90050) Boston Scientific Corporation K240018 02/01/2024
watchman truseal access system Boston Scientific K180864 07/20/2018
watchman fxd curve access system Boston Scientific Corporation K212228 08/13/2021
ultra-soft sv balloon dilatation catheter BOSTON SCIENTIFIC CORP. K050389 05/25/2005
ultra -thin sds balloon dilatation catheter BOSTON SCIENTIFIC CORP. K011889 12/21/2001
tracker excel -14 pre-shaped microcatheter BOSTON SCIENTIFIC CORP. K050599 06/03/2005
stingray lp catheter Boston Scientific K231176 05/25/2023
stingray lp catheter BOSTON SCIENTIFIC CORPORATION K152401 12/04/2015
sterling sl monorail pta balloon dilatation catheters sterling sl over-the-wire balloon dilatation catheters model vario BOSTON SCIENTIFIC CORP. K093720 12/23/2009
sterling otw pta balloon dilatation catheter, model h74939032-xxxxxx BOSTON SCIENTIFIC CORP. K053116 12/16/2005
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