Definition: Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System
| Device Type ID | 971 |
| Device Name | Reprocessed Catheter Introducer |
| Physical State | Sheath With Lumen(s). Polymer-based Shaft Material For Both Introducer And Dilator. Reprocessed Device. |
| Technical Method | The Devices Navigate To The Target Location And Facilitate The Introduction Of Cardiovascular Catheters To The Target Location. |
| Target Area | Heart And Vasculature (coronary And Peripheral) |
| Regulation Description | Catheter Introducer. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 971 |
| Device | Reprocessed Catheter Introducer |
| Product Code | PNE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Catheter Introducer. |
| CFR Regulation Number | 870.1340 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INNOVATIVE HEALTH, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERILMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERILMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Fragmentation | 1 |
Break | 1 |
Cap | 1 |
| Total Device Problems | 3 |