| Device Type ID | 849 |
| Device Name | Probe, Thermodilution |
| Regulation Description | Thermodilution Probe. |
| 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 | 870.1915 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KRB |
| 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 | 849 |
| Device | Probe, Thermodilution |
| Product Code | KRB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thermodilution Probe. |
| CFR Regulation Number | 870.1915 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PULSION MEDICAL SYSTEMS SE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 16 |
Leak / Splash | 13 |
Disconnection | 4 |
Incorrect Measurement | 4 |
Difficult To Insert | 3 |
Material Rupture | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Material Fragmentation | 2 |
Appropriate Term/Code Not Available | 2 |
Fracture | 2 |
Device Contamination With Chemical Or Other Material | 1 |
Detachment Of Device Or Device Component | 1 |
Break | 1 |
| Total Device Problems | 54 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ICU Medical, Inc. | II | Dec-22-2018 |
| 2 | Pulsion Medical Inc | II | Feb-17-2015 |