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FDA 510(k)

CerusEndo Microcatheter (027)

K-Number: K213314 · 2022-03-15

ApplicantCerus Endovascular, Inc.
Decision Date2022-03-15
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CerusEndo Microcatheter (027) is the device name listed in this FDA 510(k) record. The listed applicant is Cerus Endovascular, Inc.. It received FDA 510(k) clearance on 2022-03-15 under 510(k) number K213314. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CerusEndo Microcatheter (027)?

CerusEndo Microcatheter (027) is a medical device that received FDA 510(k) clearance on 2022-03-15. The listed applicant is Cerus Endovascular, Inc.. The 510(k) number is K213314.

When did CerusEndo Microcatheter (027) receive FDA 510(k) clearance?

CerusEndo Microcatheter (027) received FDA 510(k) clearance on 2022-03-15, under 510(k) number K213314.

Who is the listed applicant for CerusEndo Microcatheter (027)?

The FDA 510(k) record lists Cerus Endovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CerusEndo Microcatheter (027)?

The FDA product code for CerusEndo Microcatheter (027) is QJP.

Other records listing Cerus Endovascular, Inc. 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.

K182487CerusEndo Microcatheter

Related Devices (Code: QJP)

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.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

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.

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