FDA 510(k)

Argos

K-Number: K181372 · 2018-12-13

Decision Date2018-12-13

Product CodeDXG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Argos is the device name listed in this FDA 510(k) record. The listed applicant is Retia Medical, LLC. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K181372. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Argos?

Argos is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Retia Medical, LLC. The 510(k) number is K181372.

When did Argos receive FDA 510(k) clearance?

Argos received FDA 510(k) clearance on 2018-12-13, under 510(k) number K181372.

Who is the listed applicant for Argos?

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

What is the FDA product code for Argos?

The FDA product code for Argos is DXG.

Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker Medical K232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical K212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SE K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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.