Atlas FDA

QCX

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Retrograde Intubation Set
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5095
Medical specialty
Anesthesiology
Flags
Third-party review eligible
FDA definition
A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (21 CFR 8685090), syringe (21 CFR 880.5860), and hemostats (21 CFR 878.4800).
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RecordFirmDate
Retrograde Intubation Set (DEN170055)Cook Incorporated2018-12-12

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