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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 the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2025-04-29 under 510(k) 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. The listed applicant is Teleflex Medical. The 510(k) number is K242495.

When did LMA Fastrach ETT SU receive FDA 510(k) clearance?

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

Who is the listed applicant for LMA Fastrach ETT SU?

The FDA 510(k) record lists Teleflex Medical as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for LMA Fastrach ETT SU is BTR.

Other records listing Teleflex Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 26 devices →

Related Devices (Code: BTR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.