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FDA 510(k)

Glidesheath Slender Tibial Pedal Kit

K-Number: K193160 · 2019-12-03

ApplicantTerumo Medical Coporation
Decision Date2019-12-03
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Glidesheath Slender Tibial Pedal Kit is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Coporation. It received FDA 510(k) clearance on 2019-12-03 under 510(k) 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. The listed applicant is Terumo Medical Coporation. The 510(k) number is K193160.

When did Glidesheath Slender Tibial Pedal Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Glidesheath Slender Tibial Pedal Kit?

The FDA 510(k) record lists Terumo Medical Coporation as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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