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FDA 510(k)

074 Zenith Flex System

K-Number: K181354 · 2018-10-25

ApplicantInneuroco, Inc.
Decision Date2018-10-25
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

074 Zenith Flex System is the device name listed in this FDA 510(k) record. The listed applicant is Inneuroco, Inc.. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K181354. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 074 Zenith Flex System?

074 Zenith Flex System is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Inneuroco, Inc.. The 510(k) number is K181354.

When did 074 Zenith Flex System receive FDA 510(k) clearance?

074 Zenith Flex System received FDA 510(k) clearance on 2018-10-25, under 510(k) number K181354.

Who is the listed applicant for 074 Zenith Flex System?

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

What is the FDA product code for 074 Zenith Flex System?

The FDA product code for 074 Zenith Flex System is NRY.

Other records listing Inneuroco, Inc. as applicant

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Related Devices (Code: NRY)

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.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited

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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