FDA 510(k) Applications Submitted by TERUMO MEDICAL CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K112382 08/18/2011 TERUMO ASPRIATION CATHETER Terumo Medical Corporation
K122980 09/26/2012 GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ Terumo Medical Corporation
K152173 08/04/2015 Glidesheath TERUMO MEDICAL CORPORATION
K142183 08/08/2014 GLIDESHEATH SLENDER Terumo Medical Corporation
K181237 05/10/2018 Glidesheath Slender Tibial Pedal Kit Terumo Medical Corporation
K171491 05/22/2017 R2P Destination Slender Guiding Sheath Terumo Medical Corporation
K152525 09/03/2015 TR BAND Radial Compression Device TERUMO MEDICAL CORPORATION
K172995 09/27/2017 Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Terumo Medical Corporation
K213531 11/05/2021 TR BAND Radial Compression Device Terumo Medical Corporation
K193125 11/12/2019 R2P Destination Slender Guiding Sheath Terumo Medical Corporation
K173831 12/18/2017 Glidesheath Slender Terumo Medical Corporation
K151471 06/01/2015 Radifocus Glidewire Endoscopic Wire Terumo Medical Corporation
K231044 04/12/2023 R2P Navicross Terumo Medical Corporation
K122590 08/24/2012 RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE Terumo Medical Corporation


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