Medical Device Manufacturer · US , San Jose , CA

Boston Scientific Corp

432 submissions · 411 cleared · Since 1988
432
Total
411
Cleared
0
Denied

Boston Scientific Corp — FDA 510(k) Submissions

Boston Scientific Corp has submitted 432 FDA 510(k) premarket notifications since 1988, of which 411 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Angioplasty, Peripheral, Transluminal, Stents, Drains And Dilators For The Biliary Ducts, Wire, Guide, Catheter, Catheter, Intravascular, Diagnostic, System, Balloon, Intra-aortic And Control . Use the specialty filter in the sidebar to narrow results.

432 devices
1–25 of 432
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)
K243245 · GEH Unit, Cryosurgical,... · General & Plastic Surgery
Oct 2024 7d
LUX-Dx II (M302); LUX-Dx II+ (M312)
K231328 · MXD Recorder, Event,... · Cardiovascular
Aug 2023 103d
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
K152853 · FGE Stents, Drains And... · Gastroenterology & Urology
Nov 2015 52d
AXIOS Stent with Electrocautery Enhanced Delivery System
K150692 · PCU Pancreatic Stent,... · Gastroenterology & Urology
Aug 2015 140d
XXL Vascular Balloon Dilatation Catheter
K150303 · LIT Catheter, Angioplasty,... · Cardiovascular
Jun 2015 129d
Chariot Guiding Sheath
K150186 · DYB Introducer, Catheter · Cardiovascular
Jun 2015 129d
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
K150679 · PIF Gastrointestinal Tubes... · Gastroenterology & Urology
May 2015 73d
JAGWIRE HIGH PERFORMANCE GUIDWIRE
K141820 · OCY Endoscopic Guidewire,... · Gastroenterology & Urology
Oct 2014 106d
EXPEL APD DRAINAGE CATHETER SYSTEM
K141335 · FGE Stents, Drains And... · Gastroenterology & Urology
Oct 2014 149d
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
K141344 · FAD Stent, Ureteral · Gastroenterology & Urology
Oct 2014 148d
PTA BALLOON DILATATION CATHETER
K141150 · LIT Catheter, Angioplasty,... · Cardiovascular
Sep 2014 143d
Direxion Torqueable Microcatheter
K142259 · KRA Catheter, Continuous Flush · Cardiovascular
Sep 2014 27d
EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · MJN Catheter, Intravascular... · Cardiovascular
Jul 2014 169d
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV
K140726 · FDI Snare, Flexible · Gastroenterology & Urology
Jul 2014 119d
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
K141185 · DQK Computer, Diagnostic,... · Cardiovascular
Jun 2014 30d
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
K140495 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2014 49d
ENCORE 26 ADVANTAGE KIT
K140745 · MAV Syringe, Balloon Inflation · Cardiovascular
Apr 2014 23d
TRUEPATH CTO DEVICE
K140288 · PDU Catheter For Crossing... · Cardiovascular
Apr 2014 70d
INSERTION TOOL
K140673 · DQX Wire, Guide, Catheter · Cardiovascular
Apr 2014 29d
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
K132810 · LIT Catheter, Angioplasty,... · Cardiovascular
Feb 2014 172d
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
K133566 · MCW Catheter, Peripheral,... · Cardiovascular
Dec 2013 30d
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K133208 · KRD Device, Vascular, For... · Cardiovascular
Nov 2013 27d
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
K131700 · FDI Snare, Flexible · Gastroenterology & Urology
Nov 2013 146d
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · PDU Catheter For Crossing... · Cardiovascular
Oct 2013 127d
OCCLUSION BALLOON CATHETER
K132990 · MJN Catheter, Intravascular... · Cardiovascular
Oct 2013 28d

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