Boston Scientific
FDA 510(k) medical device clearances.
Top product codes for Boston Scientific
Recent clearances by Boston Scientific
- K260816 — OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)
- K252910 — Orca Air/Water and Suction Valves
- K251291 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- K250468 — iSLEEVE Introducer Set
- K242950 — WallFlex Biliary PLUS RX Stent System
- K242507 — OBSIDIO Conformable Embolic
- K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
- K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
- K234002 — ICEfx Cryoablation System (FPRCH8000-02)
- K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter
- K232635 — IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
- K231176 — Stingray LP Catheter
- K230503 — Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable
- K220866 — EKOS+ Endovascular Device
- K220629 — Emerge Monorail PTCA Dilatation Catheter
- K211080 — EkoSonic Endovascular Device
- K210925 — Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
- K201178 — iLab Polaris Multi-Modality Guidance System
- K190184 — iSLEEVE Introducer Set
- K180068 — ORISE Gel
- K180864 — WATCHMAN TruSeal Access System
- K180102 — Embozene Color-Advanced Microspheres
- K180795 — JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
- K173400 — ORISE Tissue Retractor System
- K173184 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
- K163058 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
- K160751 — Symphion Endoscope and Symphion Cervical Sheath
- DEN150040 — WallFlex Biliary RX Fully Covered Stent System RMV
- K152607 — Express SD Biliary Monorail Premounted Stent System
- K152403 — Permanent Sled Bag
- K152316 — iLab Ultrasound Imaging System
- K143193 — Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
- K141112 — STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
- K140630 — WALLFLEX BILIARY RX STENT SYSTEM
- K140329 — RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
- K140503 — FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
- K132914 — ACUITY PRO LEAD DELIVERY SYSTEM
- K140323 — NAVIGATOR HD URETERAL ACCESS SHEATH SETS
- K132253 — REMOVABLE PATIENT LEADS ECG CABLE
- K123765 — GUIDEZILLA GUIDE EXTENSION CATHETER
- K113681 — GLADIATOR PTA BALLOON DILATION CATHETER
- K112697 — CHARGER PTA BALLON DILATATION CATHETER
- K112303 — RUBICON SUPPORT CATHETER
- K112701 — CHARGER BALLOON DILATATION CATHETER
- K110122 — MUSTANG BALLOON DILATAION CATHETERS
- K103751 — MUSTANG BALLOON DILATATION CATHETERS
- K102912 — INTERLOCK FIBERED IDC OCCLUSION SYSTEM
- K091131 — PELVIC FLOOR REPAIR SYSTEM
- K070002 — BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
- K070951 — 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
- K062387 — SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
- K062050 — FLEXVIEW SYSTEM
- K040787 — MODIFICATION TO SURGICAL MESH POLYMERIC
- K040027 — BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
- K022067 — CONVOY ADVANCED DELIVERY SHEATH
- K020110 — MODIFICATION TO TRELEX MESH SURGICAL MESH
- K020028 — 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX
- K013866 — CONVOY ADVANCED DELIVERY SHEATH KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.