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 | 930 |
| Device Name | Cardiac Catheterization 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 | Diagnostic Intravascular Catheter. |
| 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 | 870.1200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OES |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 930 |
| Device | Cardiac Catheterization Kit |
| Product Code | OES |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Intravascular Catheter. |
| CFR Regulation Number | 870.1200 [🔎] |
| Device Problems | |
|---|---|
Crack | 2 |
Detachment Of Device Or Device Component | 2 |
Loose Or Intermittent Connection | 1 |
Detachment Of Device Component | 1 |
Air Leak | 1 |
Material Separation | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Catheter | 1 |
| Total Device Problems | 10 |