| Device Type ID | 727 |
| Device Name | Probe, Blood-flow, Extravascular |
| Regulation Description | Extravascular Blood Flow 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 | 870.2120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DPT |
| 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 | 727 |
| Device | Probe, Blood-flow, Extravascular |
| Product Code | DPT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Extravascular Blood Flow Probe. |
| CFR Regulation Number | 870.2120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DELTEX MEDICAL LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MOOR INSTRUMENTS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MOOR INSTRUMENTS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 5 |
Insufficient Information | 2 |
| Total Device Problems | 7 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Edwards Lifesciences, LLC | II | Sep-18-2015 |