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U.S. Department of Health and Human Services

Product Classification

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Device retrograde intubation set
Regulation Description Retrograde intubation device.
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).
Physical State Retrograde intubation sets may be comprised of guide wire and ventilating or non-ventilating intubation catheters.
Technical Method An introducer in the cricothyroid membrane allows a guide wire to pass through to be retrieved from the patient mouth or nose. The intubating catheter is inserted along the guide wire to the depth of the cricothyroid membrane. The endotracheal tube is advanced over the intubating catheter into the trachea to access airways that are difficult to intubate and ventilate.
Target Area Cricothyroid membrane, trachea, oral, nasal, upper airway
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeQCX
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5095
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons