| Device Type ID | 889 |
| Device Name | Catheter, Intracardiac Mapping, High-density Array |
| Regulation Description | Electrode Recording Catheter Or Electrode Recording Probe. |
| 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 | 870.1220 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MTD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 889 |
| Device | Catheter, Intracardiac Mapping, High-density Array |
| Product Code | MTD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrode Recording Catheter Or Electrode Recording Probe. |
| CFR Regulation Number | 870.1220 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ST. JUDE MEDICAL (ABBOTT LABORATORIES) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ST. JUDE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 31 |
Detachment Of Device Or Device Component | 23 |
Sharp Edges | 7 |
Entrapment Of Device | 6 |
Device Contamination With Chemical Or Other Material | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Bent | 5 |
Device Displays Incorrect Message | 4 |
Material Deformation | 4 |
Ring | 4 |
Device Damaged By Another Device | 4 |
Scratched Material | 4 |
Break | 4 |
Device Issue | 3 |
Coagulation In Device Or Device Ingredient | 3 |
Material Frayed | 3 |
Signal Artifact | 3 |
Catheter | 2 |
Material Split, Cut Or Torn | 2 |
Electrical /Electronic Property Problem | 2 |
Difficult To Remove | 2 |
Physical Resistance | 2 |
Failure To Adhere Or Bond | 2 |
Hole In Material | 2 |
Material Separation | 2 |
Complete Blockage | 1 |
Material Fragmentation | 1 |
Folded | 1 |
Device Packaging Compromised | 1 |
Material Protrusion / Extrusion | 1 |
Device-Device Incompatibility | 1 |
Collapse | 1 |
Display Or Visual Feedback Problem | 1 |
Fluid Leak | 1 |
Stretched | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Noise, Audible | 1 |
Separation Problem | 1 |
Sensor | 1 |
Ambient Noise Problem | 1 |
Impedance Problem | 1 |
Contamination During Use | 1 |
Failure To Read Input Signal | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
False Reading From Device Non-Compliance | 1 |
Contamination / Decontamination Problem | 1 |
Occlusion Within Device | 1 |
Difficult Or Delayed Positioning | 1 |
Tip | 1 |
Appropriate Term/Code Not Available | 1 |
No Display / Image | 1 |
Material Puncture / Hole | 1 |
Retraction Problem | 1 |
Use Of Device Problem | 1 |
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 165 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Electrophysiology | III | Aug-28-2015 |
| 2 | Biosense Webster, Inc. | II | Dec-07-2017 |
| 3 | Biosense Webster, Inc. | II | Apr-29-2016 |
| 4 | Biosense Webster, Inc. | II | Mar-11-2014 |