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FDA 510(k)

Salem Sump Dual Lumen Stomach Tube with ENFit Connection

K-Number: K190923 · 2019-11-07

ApplicantCardinalhealth
Decision Date2019-11-07
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Salem Sump Dual Lumen Stomach Tube with ENFit Connection is a medical device manufactured by Cardinalhealth. It received FDA 510(k) clearance on 2019-11-07 under approval number K190923. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Salem Sump Dual Lumen Stomach Tube with ENFit Connection?

Salem Sump Dual Lumen Stomach Tube with ENFit Connection is a medical device that received FDA 510(k) clearance on 2019-11-07. It is manufactured by Cardinalhealth. The 510(k) number is K190923.

When was Salem Sump Dual Lumen Stomach Tube with ENFit Connection approved by the FDA?

Salem Sump Dual Lumen Stomach Tube with ENFit Connection received FDA 510(k) clearance on 2019-11-07, under approval number K190923.

What company makes Salem Sump Dual Lumen Stomach Tube with ENFit Connection?

Salem Sump Dual Lumen Stomach Tube with ENFit Connection is manufactured by Cardinalhealth.

What is the FDA product code for Salem Sump Dual Lumen Stomach Tube with ENFit Connection?

The FDA product code for Salem Sump Dual Lumen Stomach Tube with ENFit Connection is PIF.

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Related Devices (Code: PIF)

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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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