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FDA 510(k)

Glidesheath Slender Tibial Pedal Kit

K-Number: K181237 · 2018-08-03

ApplicantTerumo Medical Corporation
Decision Date2018-08-03
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Glidesheath Slender Tibial Pedal Kit is a medical device manufactured by Terumo Medical Corporation. It received FDA 510(k) clearance on 2018-08-03 under approval number K181237. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Glidesheath Slender Tibial Pedal Kit?

Glidesheath Slender Tibial Pedal Kit is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by Terumo Medical Corporation. The 510(k) number is K181237.

When was Glidesheath Slender Tibial Pedal Kit approved by the FDA?

Glidesheath Slender Tibial Pedal Kit received FDA 510(k) clearance on 2018-08-03, under approval number K181237.

What company makes Glidesheath Slender Tibial Pedal Kit?

Glidesheath Slender Tibial Pedal Kit is manufactured by Terumo Medical Corporation.

What is the FDA product code for Glidesheath Slender Tibial Pedal Kit?

The FDA product code for Glidesheath Slender Tibial Pedal Kit is DYB.

Related Clinical Trials

NCT07410364 Safety and Efficacy of CAG and PCI Via Distal Transradial Access in Patients With Small Vessels RECRUITING NCT07218406 Comparison of Merit Prelude Ideal and Terumo Glidesheath Slender Radial Artery Sheaths COMPLETED

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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