| Device Type ID | 728 |
| Device Name | Flowmeter, Blood, Cardiovascular |
| Regulation Description | Cardiovascular Blood Flowmeter. |
| 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 | 870.2100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DPW |
| 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 | 728 |
| Device | Flowmeter, Blood, Cardiovascular |
| Product Code | DPW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiovascular Blood Flowmeter. |
| CFR Regulation Number | 870.2100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DELTEX MEDICAL LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OR-NIM MEDICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PERIMED AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRANSONIC SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 7 |
Electrical /Electronic Property Problem | 1 |
Device Operates Differently Than Expected | 1 |
Pumping Stopped | 1 |
Insufficient Information | 1 |
Noise, Audible | 1 |
| Total Device Problems | 12 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corp. | II | May-10-2016 |
| 2 | Baxter Healthcare Corporation | II | Jul-29-2014 |
| 3 | Medistim Asa | II | Feb-26-2018 |
| 4 | Transonic Systems Inc | II | Sep-03-2015 |
| 5 | Vascular Technology, Inc. | II | Sep-12-2018 |
| 6 | Vascular Technology, Inc. | II | Jul-07-2014 |