Medical Device Manufacturer · US , S,Mta Clara , CA

Abbott Vascular - FDA 510(k) Cleared Devices

30 submissions · 30 cleared · Since 2009

Recent clearances: NC TREK NEO Coronary Dilatation Catheter, Viatrac 14 Plus Peripheral Dilatation Catheter, HI-TORQUE PROCEED Guide Wire Family

30

Total

30

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Vascular Cardiovascular ✕

30 devices

1-12 of 30

Cleared Jun 30, 2022

NC TREK NEO Coronary Dilatation Catheter

Cardiovascular · 118d

Cleared May 05, 2022

Viatrac 14 Plus Peripheral Dilatation Catheter

Cardiovascular · 24d

Cleared Jul 30, 2020

HI-TORQUE PROCEED Guide Wire Family

Cardiovascular · 28d

Cleared Apr 08, 2020

HI-TORQUE Steelcore Bare Guide Wire

Cardiovascular · 77d

Cleared Dec 11, 2019

HI-TORQUE InfilTrac Guide Wire Family

Cardiovascular · 29d

Cleared Jul 25, 2019

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

Cardiovascular · 85d

Cleared Aug 24, 2018

NC TREK™ RX Coronary Dilatation Catheter

Cardiovascular · 231d

Cleared Jan 12, 2018

HI-TORQUE TurnTrac Guide Wire Family

Cardiovascular · 29d

Cleared Sep 06, 2017

Steerable Guide Catheter

Cardiovascular · 29d

Cleared Aug 25, 2017

Hi-Torque Command 18 Guide Wire

Cardiovascular · 46d

Cleared Aug 07, 2016

Steerable Guide Catheter

Cardiovascular · 19d

Cleared Nov 20, 2015

RX ACCUNET Embolic Protection System

Cardiovascular · 25d