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FDA 510(k)

LMA Fastrach ETT SU

K-Number: K242495 · 2025-04-29

Decision Date2025-04-29
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LMA Fastrach ETT SU is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2025-04-29 under approval number K242495. 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 LMA Fastrach ETT SU?

LMA Fastrach ETT SU is a medical device that received FDA 510(k) clearance on 2025-04-29. It is manufactured by Teleflex Medical. The 510(k) number is K242495.

When was LMA Fastrach ETT SU approved by the FDA?

LMA Fastrach ETT SU received FDA 510(k) clearance on 2025-04-29, under approval number K242495.

What company makes LMA Fastrach ETT SU?

LMA Fastrach ETT SU is manufactured by Teleflex Medical.

What is the FDA product code for LMA Fastrach ETT SU?

The FDA product code for LMA Fastrach ETT SU 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.