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 |