Laser-Flex(Tm) Tracheal Tube (Cuffed)

by Mallinckrodt Critical Care 510(k)

Active United States

510(k) K873461

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK873461	Date6 Nov 1987Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K873461
FDA Product Code: BTR

Device Class: Class II
Regulation: 21 CFR Part 868.5730
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

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