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FDA 510(k)

Glidesheath Slender

K-Number: K173831 · 2018-05-08

ApplicantTerumo Medical Corporation
Decision Date2018-05-08
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Glidesheath Slender is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corporation. It received FDA 510(k) clearance on 2018-05-08 under 510(k) number K173831. 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?

Glidesheath Slender is a medical device that received FDA 510(k) clearance on 2018-05-08. The listed applicant is Terumo Medical Corporation. The 510(k) number is K173831.

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

Glidesheath Slender received FDA 510(k) clearance on 2018-05-08, under 510(k) number K173831.

Who is the listed applicant for Glidesheath Slender?

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

What is the FDA product code for Glidesheath Slender?

The FDA product code for Glidesheath Slender is DYB.

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Other records listing Terumo Medical Corporation as applicant

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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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