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FDA 510(k)

CerusEndo Microcatheter

K-Number: K182487 · 2019-07-20

ApplicantCerus Endovascular, Inc.
Decision Date2019-07-20
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CerusEndo Microcatheter 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 2019-07-20 under 510(k) number K182487. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CerusEndo Microcatheter?

CerusEndo Microcatheter is a medical device that received FDA 510(k) clearance on 2019-07-20. The listed applicant is Cerus Endovascular, Inc.. The 510(k) number is K182487.

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

CerusEndo Microcatheter received FDA 510(k) clearance on 2019-07-20, under 510(k) number K182487.

Who is the listed applicant for CerusEndo Microcatheter?

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?

The FDA product code for CerusEndo Microcatheter is DQY.

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.

K213314CerusEndo Microcatheter (027)

Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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