Boston Scientific - FDA 510(k) Cleared Devices

Cleared Jan 30, 2017

Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle

K163058 · ODG

Gastroenterology & Urology · 90d

Cleared Jun 14, 2016

Symphion Endoscope and Symphion Cervical Sheath

K160751 · HIH

Obstetrics & Gynecology · 88d

Not Cleared Jun 03, 2016

WallFlex Biliary RX Fully Covered Stent System RMV

DEN150040 · PNB

Gastroenterology & Urology · 280d

Cleared Oct 27, 2015

Express SD Biliary Monorail Premounted Stent System

K152607 · FGE

Gastroenterology & Urology · 46d

Cleared Sep 22, 2015

Permanent Sled Bag

K152403 · ITX

Radiology · 28d

Cleared Sep 18, 2015

iLab Ultrasound Imaging System

K152316 · IYO

Radiology · 32d

Cleared Jul 24, 2015

Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters

K143193 · LIT

Cardiovascular · 260d

Cleared Jul 16, 2014

STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER

K141112 · LIT

Cardiovascular · 77d

Cleared May 23, 2014

WALLFLEX BILIARY RX STENT SYSTEM

K140630 · FGE

Gastroenterology & Urology · 73d

Cleared May 15, 2014

RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT

K140329 · KRA

Cardiovascular · 94d

Cleared Apr 15, 2014

FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER

K140503 · GEX

General & Plastic Surgery · 47d

Cleared Apr 03, 2014

ACUITY PRO LEAD DELIVERY SYSTEM

K132914 · DQY

Cardiovascular · 198d

Cleared Mar 07, 2014

NAVIGATOR HD URETERAL ACCESS SHEATH SETS

K140323 · FED

Gastroenterology & Urology · 25d

Cleared Dec 16, 2013

REMOVABLE PATIENT LEADS ECG CABLE

K132253 · DSA

Cardiovascular · 150d

Cleared Mar 19, 2013

GUIDEZILLA GUIDE EXTENSION CATHETER

K123765 · DQY

Cardiovascular · 102d

Cleared Jan 11, 2012

GLADIATOR PTA BALLOON DILATION CATHETER

K113681 · LIT

Cardiovascular · 27d

Cleared Nov 30, 2011

CHARGER PTA BALLON DILATATION CATHETER

K112697 · LIT

Cardiovascular · 75d

Cleared Nov 09, 2011

RUBICON SUPPORT CATHETER

K112303 · DQY

Cardiovascular · 90d

Cleared Oct 25, 2011

CHARGER BALLOON DILATATION CATHETER

K112701 · FGE

Gastroenterology & Urology · 39d

Cleared May 12, 2011

MUSTANG BALLOON DILATAION CATHETERS

K110122 · FGE

Gastroenterology & Urology · 114d

Cleared Mar 22, 2011

MUSTANG BALLOON DILATATION CATHETERS

K103751 · LIT

Cardiovascular · 89d

Cleared Mar 03, 2011

INTERLOCK FIBERED IDC OCCLUSION SYSTEM

K102912 · KRD

Cardiovascular · 153d

Cleared May 08, 2009

PELVIC FLOOR REPAIR SYSTEM

K091131 · OTP

Obstetrics & Gynecology · 18d

Cleared Aug 17, 2007

BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER

K070002 · LJS

General Hospital · 226d

Cleared Jun 04, 2007

2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH...

K070951 · PNO

Cardiovascular · 61d