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 | 936 |
| Device Name | Cardiovascular Surgical Instruments Tray |
| 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 | Cardiovascular Surgical Instruments. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 870.4500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OFA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 936 |
| Device | Cardiovascular Surgical Instruments Tray |
| Product Code | OFA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cardiovascular Surgical Instruments. |
| CFR Regulation Number | 870.4500 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Centurion Medical Products Corporation | II | Jan-08-2015 |
| 2 | Customed, Inc | II | Apr-14-2016 |
| 3 | Customed, Inc | II | Sep-03-2015 |
| 4 | Customed, Inc | I | Dec-16-2014 |
| 5 | Customed, Inc | I | Aug-29-2014 |