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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 a medical device manufactured by Cordis Corporation. It received FDA 510(k) clearance on 2018-04-18 under approval 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. It is manufactured by Cordis Corporation. The 510(k) number is K180081.

When was RAILWAY Sheathless Access System approved by the FDA?

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

What company makes RAILWAY Sheathless Access System?

RAILWAY Sheathless Access System is manufactured by Cordis Corporation.

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 PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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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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