SpyGlass Discover Balloon Dilation Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL

FDA 510(k)

FDA Class 2 ·Cardiovascular

WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXALT Model D Single-Use Duodenoscope, EXALT Controller

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels

FDA 510(k)

FDA Class 2 ·Cardiovascular

FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAMBA and MAMBA FLEX Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIKING™ Fixed Curve Diagnostic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Comet II Pressure Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Capio SLIM Suture Capturing Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rubicon™ Control Support Catheter (H749394323506A1)

FDA 510(k)

FDA Class 2 ·Cardiovascular