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 Kit, As Described In The Guidance Above, Is Under Enforcemen
| Device Type ID | 2736 |
| Device Name | Chest Drainage 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 Kit, As Described In The Guidance Above, Is Under Enforcemen |
| 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 Kit, As Described In The Guidance Above, Is Under Enforcemen |
| 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 Kit, As Described In The Guidance Above, Is Under Enforcemen |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 880.6740 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PAD |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2736 |
| Device | Chest Drainage Kit |
| Product Code | PAD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| CFR Regulation Number | 880.6740 [🔎] |
| Device Problems | |
|---|---|
Occlusion Within Device | 2 |
Suction Problem | 2 |
Use Of Device Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Decrease In Suction | 1 |
Device Damaged Prior To Use | 1 |
Stylet | 1 |
Defective Device | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Atrium Medical Corporation | II | Jan-24-2017 |
| 2 | Atrium Medical Corporation | II | Jun-29-2015 |