FDA 510(k)

046 Zenith Flex

K-Number: K190338 · 2019-08-02

Decision Date2019-08-02

Product CodeNRY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

046 Zenith Flex is a medical device manufactured by Inneuroco, Inc.. It received FDA 510(k) clearance on 2019-08-02 under approval number K190338. 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 046 Zenith Flex?

046 Zenith Flex is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by Inneuroco, Inc.. The 510(k) number is K190338.

When was 046 Zenith Flex approved by the FDA?

046 Zenith Flex received FDA 510(k) clearance on 2019-08-02, under approval number K190338.

What company makes 046 Zenith Flex?

046 Zenith Flex is manufactured by Inneuroco, Inc..

What is the FDA product code for 046 Zenith Flex?

The FDA product code for 046 Zenith Flex is NRY.

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 K181354074 Zenith Flex System K172167Zenith Flex System K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm

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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.