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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 the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical Components, LLC. It received FDA 510(k) clearance on 2019-12-19 under 510(k) 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. The listed applicant is Heraeus Medical Components, LLC. The 510(k) number is K191305.

When did Hereaeus Poseidon Microcatheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Hereaeus Poseidon Microcatheter?

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

What is the FDA product code for Hereaeus Poseidon Microcatheter?

The FDA product code for Hereaeus Poseidon Microcatheter is KRA.

Other records listing Heraeus Medical Components, LLC as applicant

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.

K191502Heraeus Peripheral GuidewireK170664Odyssey Micro CatheterK173052Heraeus TMW Guidewire

Related Devices (Code: KRA)

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.

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech LimitedK231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLCK231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc.

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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