FDA 510(k)

Glidesheath Slender Tibial Pedal Kit

K-Number: K193160 · 2019-12-03

Decision Date2019-12-03

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Glidesheath Slender Tibial Pedal Kit is a medical device manufactured by Terumo Medical Coporation. It received FDA 510(k) clearance on 2019-12-03 under approval number K193160. 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 2019-12-03. It is manufactured by Terumo Medical Coporation. The 510(k) number is K193160.

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

Glidesheath Slender Tibial Pedal Kit received FDA 510(k) clearance on 2019-12-03, under approval number K193160.

What company makes Glidesheath Slender Tibial Pedal Kit?

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

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

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