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FDA 510(k)

Sheridan Spiral-Flex Endotracheal Tubes

K-Number: K192324 · 2019-12-06

Decision Date2019-12-06
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sheridan Spiral-Flex Endotracheal Tubes is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2019-12-06 under approval number K192324. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sheridan Spiral-Flex Endotracheal Tubes?

Sheridan Spiral-Flex Endotracheal Tubes is a medical device that received FDA 510(k) clearance on 2019-12-06. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K192324.

When was Sheridan Spiral-Flex Endotracheal Tubes approved by the FDA?

Sheridan Spiral-Flex Endotracheal Tubes received FDA 510(k) clearance on 2019-12-06, under approval number K192324.

What company makes Sheridan Spiral-Flex Endotracheal Tubes?

Sheridan Spiral-Flex Endotracheal Tubes is manufactured by Teleflexmedical, Inc..

What is the FDA product code for Sheridan Spiral-Flex Endotracheal Tubes?

The FDA product code for Sheridan Spiral-Flex Endotracheal Tubes is BTR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.