FDA-Device2024-11-06Class II
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
King Systems Corp. dba Ambu, Inc.
Hazard
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Sold states
Nationwide
Affected count
31457 units
Manufactured in
15011 Herriman Blvd, N/A, Noblesville, IN, United States
Products
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0272-2025Don't want to check this manually?
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