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FDA 510(k)

RAILWAY Sheathless Access System

K-Number: K180081 · 2018-04-18

ApplicantCordis Corporation
Decision Date2018-04-18
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RAILWAY Sheathless Access System is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corporation. It received FDA 510(k) clearance on 2018-04-18 under 510(k) number K180081. 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 RAILWAY Sheathless Access System?

RAILWAY Sheathless Access System is a medical device that received FDA 510(k) clearance on 2018-04-18. The listed applicant is Cordis Corporation. The 510(k) number is K180081.

When did RAILWAY Sheathless Access System receive FDA 510(k) clearance?

RAILWAY Sheathless Access System received FDA 510(k) clearance on 2018-04-18, under 510(k) number K180081.

Who is the listed applicant for RAILWAY Sheathless Access System?

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

What is the FDA product code for RAILWAY Sheathless Access System?

The FDA product code for RAILWAY Sheathless Access System is DYB.

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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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