Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
| Device Type ID | 1425 |
| Device Name | Cricothyrotomy Kit |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Regulation Description | Tracheostomy Tube And Tube Cuff. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 868.5800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OGP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1425 |
| Device | Cricothyrotomy Kit |
| Product Code | OGP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tracheostomy Tube And Tube Cuff. |
| CFR Regulation Number | 868.5800 [🔎] |
| Device Problems | |
|---|---|
Needle | 2 |
Aspiration Issue | 1 |
Complete Blockage | 1 |
Positioning Failure | 1 |
Guidewire | 1 |
Bent | 1 |
Wire | 1 |
Activation, Positioning Or Separation Problem | 1 |
| Total Device Problems | 9 |