FDA 510(k) Applications Submitted by Boston Scientific

FDA 510(k) Number Submission Date Device Name Applicant
K113681 12/15/2011 GLADIATOR PTA BALLOON DILATION CATHETER BOSTON SCIENTIFIC
K022067 06/25/2002 CONVOY ADVANCED DELIVERY SHEATH BOSTON SCIENTIFIC
K013866 11/21/2001 CONVOY ADVANCED DELIVERY SHEATH KIT BOSTON SCIENTIFIC
K062387 08/15/2006 SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM BOSTON SCIENTIFIC
K152607 09/11/2015 Express SD Biliary Monorail Premounted Stent System BOSTON SCIENTIFIC
K143193 11/06/2014 Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters BOSTON SCIENTIFIC
K110122 01/18/2011 MUSTANG BALLOON DILATAION CATHETERS BOSTON SCIENTIFIC
K103751 12/23/2010 MUSTANG BALLOON DILATATION CATHETERS BOSTON SCIENTIFIC
K070951 04/04/2007 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS BOSTON SCIENTIFIC
K160751 03/18/2016 Symphion Endoscope and Symphion Cervical Sheath BOSTON SCIENTIFIC
K141112 04/30/2014 STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC
K062050 07/20/2006 FLEXVIEW SYSTEM BOSTON SCIENTIFIC
K020110 01/11/2002 MODIFICATION TO TRELEX MESH SURGICAL MESH BOSTON SCIENTIFIC
K040787 03/29/2004 MODIFICATION TO SURGICAL MESH POLYMERIC BOSTON SCIENTIFIC
K152316 08/17/2015 iLab Ultrasound Imaging System BOSTON SCIENTIFIC
K152403 08/25/2015 Permanent Sled Bag BOSTON SCIENTIFIC
K112303 08/11/2011 RUBICON SUPPORT CATHETER BOSTON SCIENTIFIC
K112697 09/16/2011 CHARGER PTA BALLON DILATATION CATHETER BOSTON SCIENTIFIC
K112701 09/16/2011 CHARGER BALLOON DILATATION CATHETER BOSTON SCIENTIFIC
K180102 01/16/2018 Embozene Color-Advanced Microspheres Boston Scientific
K132914 09/17/2013 ACUITY PRO LEAD DELIVERY SYSTEM BOSTON SCIENTIFIC
K123765 12/07/2012 GUIDEZILLA GUIDE EXTENSION CATHETER BOSTON SCIENTIFIC
K140503 02/27/2014 FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER BOSTON SCIENTIFIC
K173184 09/29/2017 Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle Boston Scientific
K163058 11/01/2016 Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle BOSTON SCIENTIFIC
K140329 02/10/2014 RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT BOSTON SCIENTIFIC
K132253 07/19/2013 REMOVABLE PATIENT LEADS ECG CABLE BOSTON SCIENTIFIC
K140323 02/10/2014 NAVIGATOR HD URETERAL ACCESS SHEATH SETS BOSTON SCIENTIFIC
K180864 04/02/2018 WATCHMAN TruSeal Access System Boston Scientific
K180795 03/27/2018 JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire Boston Scientific
K140630 03/11/2014 WALLFLEX BILIARY RX STENT SYSTEM BOSTON SCIENTIFIC
DEN150040 08/28/2015 WallFlex Biliary RX Fully Covered Stent System RMV BOSTON SCIENTIFIC
K173400 10/31/2017 ORISE Tissue Retractor System Boston Scientific
K020028 01/04/2002 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX BOSTON SCIENTIFIC


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