| Device Type ID | 742 |
| Device Name | Catheter, Steerable |
| Regulation Description | Steerable Catheter. |
| 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 | 870.1280 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DRA |
| 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 | 742 |
| Device | Catheter, Steerable |
| Product Code | DRA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Steerable Catheter. |
| CFR Regulation Number | 870.1280 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CARDIOFOCUS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HANSEN MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
HANSEN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
HANSON MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 459 |
Air Leak | 267 |
Appropriate Term/Code Not Available | 190 |
Fluid Leak | 129 |
Leak / Splash | 97 |
Kinked | 71 |
Gas Leak | 61 |
Material Integrity Problem | 44 |
Material Twisted / Bent | 32 |
Detachment Of Device Component | 20 |
Break | 17 |
Insufficient Information | 13 |
Difficult To Insert | 11 |
Unintended Movement | 11 |
Difficult To Remove | 10 |
Unstable | 10 |
Valve | 10 |
Difficult Or Delayed Positioning | 9 |
Material Deformation | 9 |
Positioning Failure | 7 |
Material Split, Cut Or Torn | 7 |
Failure To Advance | 7 |
Device Operates Differently Than Expected | 7 |
Improper Or Incorrect Procedure Or Method | 6 |
Delivered As Unsterile Product | 5 |
Material Separation | 5 |
Torn Material | 5 |
Device Damaged By Another Device | 4 |
Aspiration Issue | 4 |
No Apparent Adverse Event | 4 |
Stopcock | 4 |
Catheter | 4 |
Deformation Due To Compressive Stress | 3 |
Loss Of Or Failure To Bond | 3 |
Balloon | 3 |
Physical Resistance | 3 |
Noise, Audible | 3 |
Crack | 3 |
Difficult To Position | 2 |
Device Slipped | 2 |
Detachment Of Device Or Device Component | 2 |
Difficult To Advance | 2 |
Port | 2 |
Device Displays Incorrect Message | 2 |
Hemo Valve | 2 |
Occlusion Within Device | 1 |
Deflation Problem | 1 |
Device Difficult To Setup Or Prepare | 1 |
Suction Problem | 1 |
Obstruction Of Flow | 1 |
Device Dislodged Or Dislocated | 1 |
Physical Property Issue | 1 |
Tip | 1 |
Contamination During Use | 1 |
Device Contamination With Body Fluid | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Cable | 1 |
Bent | 1 |
Positioning Problem | 1 |
Entrapment Of Device | 1 |
Loose Or Intermittent Connection | 1 |
Temperature Problem | 1 |
Mechanical Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Peeled / Delaminated | 1 |
Unsealed Device Packaging | 1 |
Off-Label Use | 1 |
| Total Device Problems | 1593 |