Medical Device Manufacturer · US , Bloomington , IN

Cook Incorporated - FDA 510(k) Cleared Devices

175 submissions · 153 cleared · Since 2006

175

Total

153

Cleared

1

Denied

FDA 510(k) cleared devices by Cook Incorporated Cardiovascular ✕

69 devices

1-12 of 69

Cleared May 16, 2023

Gunther Tulip Vena Cava Filter Retrieval Set

Cardiovascular · 293d

Cleared Apr 06, 2021

Endovascular Dilator and Sets

Cardiovascular · 26d

Cleared Feb 16, 2021

Extra Large Check-Flo Introducer

Cardiovascular · 62d

Cleared Dec 12, 2019

Lumax Guiding Catheter

Cardiovascular · 225d

Cleared Jul 22, 2019

Roadrunner PC Wire Guide, Olcott Torque Device

Cardiovascular · 266d

Cleared Apr 25, 2019

Multi-Sideport Catheter Infusion Set

Cardiovascular · 267d

Cleared Apr 04, 2019

Park Blade Septostomy Catheter

Cardiovascular · 212d

Cleared Mar 22, 2019

Polyethylene Catheter

Cardiovascular · 266d

Cleared Feb 15, 2019

Lunderquist® Fixed Core Wire Guide

Cardiovascular · 269d

Cleared Jan 11, 2019

Roadrunner Extra Support Wire Guide

Cardiovascular · 28d

Cleared Dec 20, 2018

Reuter Tip Deflecting Wire Guide

Cardiovascular · 265d

Cleared Dec 20, 2018

Cardiovascular · 49d

Looking for a specific device from Cook Incorporated? Search by device name or K-number.

Search all Cook Incorporated devices