FDA 510(k)

Hereaeus Poseidon Microcatheter

K-Number: K191305 · 2019-12-19

ApplicantHeraeus Medical Components, LLC

Decision Date2019-12-19

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Hereaeus Poseidon Microcatheter is a medical device manufactured by Heraeus Medical Components, LLC. It received FDA 510(k) clearance on 2019-12-19 under approval number K191305. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hereaeus Poseidon Microcatheter?

Hereaeus Poseidon Microcatheter is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by Heraeus Medical Components, LLC. The 510(k) number is K191305.

When was Hereaeus Poseidon Microcatheter approved by the FDA?

Hereaeus Poseidon Microcatheter received FDA 510(k) clearance on 2019-12-19, under approval number K191305.

What company makes Hereaeus Poseidon Microcatheter?

Hereaeus Poseidon Microcatheter is manufactured by Heraeus Medical Components, LLC.

What is the FDA product code for Hereaeus Poseidon Microcatheter?

The FDA product code for Hereaeus Poseidon Microcatheter is KRA.

Other Devices by Heraeus Medical Components, LLC

K170664Odyssey Micro Catheter K173052Heraeus TMW Guidewire K191502Heraeus Peripheral Guidewire

Related Devices (Code: KRA)

K161962VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC K160884CXI Support CatheterCook Incorporated K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. K161801CrossCath Support CatheterCook Incorporated K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.

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.