| Device Type ID | 738 |
| Device Name | Cannula, Catheter |
| Regulation Description | Catheter Cannula. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DQR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 738 |
| Device | Cannula, Catheter |
| Product Code | DQR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Catheter Cannula. |
| CFR Regulation Number | 870.1300 [🔎] |
| Device Problems | |
|---|---|
Break | 47 |
Activation, Positioning Or Separation Problem | 43 |
Positioning Failure | 28 |
Positioning Problem | 7 |
Fracture | 7 |
Device Issue | 5 |
Protective Measures Problem | 5 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Malposition Of Device | 3 |
No Device Output | 2 |
Blocked Connection | 2 |
Separation Failure | 2 |
Material Separation | 2 |
Leak / Splash | 2 |
Chemical Problem | 2 |
Component Missing | 2 |
Device Operates Differently Than Expected | 2 |
Device Operational Issue | 2 |
Migration Or Expulsion Of Device | 1 |
Difficult To Remove | 1 |
Uncoiled | 1 |
Connection Problem | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Fitting Problem | 1 |
Device, Removal Of (non-implant) | 1 |
Partial Blockage | 1 |
Wire(s), Breakage Of | 1 |
Detachment Of Device Or Device Component | 1 |
Torn Material | 1 |
Insufficient Information | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Stylet | 1 |
Kinked | 1 |
| Total Device Problems | 182 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | SPS Sterilization, Inc | II | Sep-13-2018 |