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
| Device Type ID | 206 |
| Device Name | Retrograde Intubation Set |
| 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 I |
| Target Area | Cricothyroid Membrane, Trachea, Oral, Nasal, Upper Airway |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5095 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QCX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |