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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 a medical device manufactured by Inneuroco, Inc.. It received FDA 510(k) clearance on 2018-10-25 under approval 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. It is manufactured by Inneuroco, Inc.. The 510(k) number is K181354.

When was 074 Zenith Flex System approved by the FDA?

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

What company makes 074 Zenith Flex System?

074 Zenith Flex System is manufactured by Inneuroco, Inc..

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

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

Related Clinical Trials

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Other Devices by Inneuroco, Inc.

K161262Super Distal Access (SDA) K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm K171672065 Zenith, 074 Zenith K172167Zenith Flex System K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm K190338046 Zenith Flex

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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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