| Device Type ID | 829 |
| Device Name | System, Catheter Control, Steerable |
| Regulation Description | Steerable Catheter Control System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Electrophysiology Devices Branch (CEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1290 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXX |
| 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 | 829 |
| Device | System, Catheter Control, Steerable |
| Product Code | DXX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Steerable Catheter Control System. |
| CFR Regulation Number | 870.1290 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CORINDUS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
HANSEN MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HANSEN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HANSON MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STEREOTAXIS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Unintended Movement | 24 |
Joystick | 3 |
Fail-Safe Problem | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Display Or Visual Feedback Problem | 2 |
Device-Device Incompatibility | 1 |
Cassette | 1 |
Device Issue | 1 |
Component Or Accessory Incompatibility | 1 |
Patient Device Interaction Problem | 1 |
Device Displays Incorrect Message | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 42 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hansen Medical Inc | II | Apr-25-2016 |
| 2 | Hansen Medical Inc | II | Apr-15-2015 |
| 3 | Hansen Medical Inc | II | Dec-30-2014 |