| Device Type ID | 732 |
| Device Name | Catheter, Oximeter, Fiber-optic |
| Regulation Description | Fiberoptic Oximeter Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1230 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DQE |
| 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 | 732 |
| Device | Catheter, Oximeter, Fiber-optic |
| Product Code | DQE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fiberoptic Oximeter Catheter. |
| CFR Regulation Number | 870.1230 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EDWARDS LIFESCIENCES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ICU MEDICAL SALES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ICU MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 29 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 25 |
Material Rupture | 21 |
Adverse Event Without Identified Device Or Use Problem | 15 |
Appropriate Term/Code Not Available | 8 |
Device Contamination With Chemical Or Other Material | 7 |
Output Problem | 6 |
Difficult To Insert | 5 |
Deflation Problem | 5 |
Inflation Problem | 3 |
Kinked | 3 |
Unable To Obtain Readings | 3 |
Positioning Problem | 3 |
Detachment Of Device Component | 3 |
Difficult To Advance | 2 |
Break | 2 |
Connection Problem | 2 |
Looping | 1 |
Incorrect Measurement | 1 |
Difficult To Remove | 1 |
Material Twisted / Bent | 1 |
Burst Container Or Vessel | 1 |
Fracture | 1 |
Defective Component | 1 |
Difficult To Position | 1 |
Shelf Life Exceeded | 1 |
Torn Material | 1 |
Calibration Error | 1 |
Knotted | 1 |
Peeled / Delaminated | 1 |
| Total Device Problems | 155 |