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 | 935 |
| Device Name | Cardiovascular Procedure 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 | OEZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 935 |
| Device | Cardiovascular Procedure Kit |
| Product Code | OEZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Intravascular Catheter. |
| CFR Regulation Number | 870.1200 [🔎] |
| Device Problems | |
|---|---|
Tear, Rip Or Hole In Device Packaging | 28 |
Air Leak | 24 |
Fluid Leak | 23 |
Disconnection | 10 |
Kit | 9 |
Connection Problem | 7 |
Device Reprocessing Problem | 6 |
Problem With Sterilization | 6 |
Crack | 4 |
Insufficient Information | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Device Misassembled During Manufacturing / Shipping | 3 |
Material Rupture | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Use Of Device Problem | 2 |
No Flow | 2 |
Uncoiled | 2 |
Fracture | 2 |
Improper Flow Or Infusion | 2 |
Filter | 2 |
Leak / Splash | 2 |
Hollow Fiber | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
One-Way Valve | 1 |
Hole In Material | 1 |
Unsealed Device Packaging | 1 |
Break | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Packaging Problem | 1 |
Device Damaged Prior To Use | 1 |
Inflation Problem | 1 |
Device Operational Issue | 1 |
Misconnection | 1 |
Inadequate Instructions For Healthcare Professional | 1 |
Particulates | 1 |
Balloon | 1 |
Contamination / Decontamination Problem | 1 |
| Total Device Problems | 164 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AngioDynamics Inc. | II | Apr-07-2016 |
| 2 | Navilyst Medical, Inc | II | Feb-26-2015 |
| 3 | Terumo Cardiovascular Systems Corp | II | Jul-26-2018 |
| 4 | Terumo Cardiovascular Systems Corp | II | Apr-06-2018 |
| 5 | Terumo Cardiovascular Systems Corp | II | Aug-31-2016 |
| 6 | Terumo Cardiovascular Systems Corp | II | Oct-31-2014 |
| 7 | Terumo Cardiovascular Systems Corp | II | Apr-16-2014 |
| 8 | Terumo Cardiovascular Systems Corporation | II | Feb-27-2019 |