| Device Type ID | 909 |
| Device Name | Catheter, Recording, Electrode, Reprocessed |
| 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 | NLH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 909 |
| Device | Catheter, Recording, Electrode, Reprocessed |
| Product Code | NLH |
| 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 | |
INNOVATIVE HEALTH, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 14 | |
STERILMED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STERILMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Defective Device | 10 |
Difficult To Remove | 6 |
Material Deformation | 5 |
Difficult To Position | 4 |
Kinked | 4 |
Positioning Problem | 3 |
Break | 3 |
Entrapment Of Device | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Device Contamination With Chemical Or Other Material | 1 |
Knotted | 1 |
Positioning Failure | 1 |
Device Packaging Compromised | 1 |
Scratched Material | 1 |
Device Damaged Prior To Use | 1 |
Insufficient Information | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Fracture | 1 |
Device Inoperable | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Structural Problem | 1 |
Catheter | 1 |
| Total Device Problems | 54 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Sustainability Solutions | II | Jan-23-2019 |
| 2 | Stryker Sustainability Solutions | II | Nov-14-2018 |
| 3 | Stryker Sustainability Solutions | II | Jul-12-2018 |
| 4 | Stryker Sustainability Solutions | II | Mar-06-2018 |
| 5 | Stryker Sustainability Solutions | II | Jan-07-2017 |
| 6 | Stryker Sustainability Solutions | II | Nov-09-2016 |
| 7 | Stryker Sustainability Solutions | II | May-23-2016 |