Medical Device Manufacturer · US , Elkton , MD

Terumo Medical Corporation - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2011

Recent clearances: R2P Navicross, TR BAND Radial Compression Device, R2P Destination Slender Guiding Sheath

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Terumo Medical Corporation Cardiovascular ✕

13 devices

1-12 of 13

Cleared Jul 27, 2023

Cardiovascular · 106d

Cleared Dec 20, 2021

TR BAND Radial Compression Device

Cardiovascular · 45d

Cleared Jan 06, 2020

R2P Destination Slender Guiding Sheath

Cardiovascular · 55d

Cleared CT Aug 03, 2018

Glidesheath Slender Tibial Pedal Kit

Cardiovascular · 85d

Cleared May 08, 2018

Glidesheath Slender

Cardiovascular · 141d

Cleared Nov 21, 2017

Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath,...

Cardiovascular · 55d

Cleared Oct 05, 2017

R2P Destination Slender Guiding Sheath

Cardiovascular · 136d

Cleared Dec 01, 2015

Cardiovascular · 119d

Cleared Nov 10, 2015

TR BAND Radial Compression Device

Cardiovascular · 68d

Cleared Nov 21, 2014

GLIDESHEATH SLENDER

Cardiovascular · 105d

Cleared Mar 01, 2013

RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE

Cardiovascular · 189d

Cleared Dec 11, 2012

GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM*...

Cardiovascular · 76d