Flowmeter, Blood, Cardiovascular

Product Code: DPW

Cardiovascular Diagnostic Ultrasound Devices

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 870.2100


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as DPW

728Flowmeter, Blood, CardiovascularCardiovascular Blood Flowmeter.

Total Product Life Cycle (TPLC) Devices

728Flowmeter, Blood, CardiovascularCardiovascular Blood Flowmeter.

Pre-market Notifications for DPW

K222242FloPatch FP120Flosonics Medical
K213974GEM FLOW COUPLER Monitor (GEM1020M-2)Synovis Micro Companies Alliance, Inc.
K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerRemington Medical, Inc.
K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerRemington Medical, Inc.
K201114Bidop 7Koven Technology, Inc.
K200337FloPatch (FP120)Flosonics Medical (r/a 1929803 Ontario Corp.)
K192966FlowMetLaser Associated Sciences, Inc.
K191388FloPatch (FP110)Flosonics Medical (r/a 1929803 Ontario Corp.)
K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesHuntleigh Healthcare Ltd
K182494FlowMet-RLaser Associated Sciences, Inc.
K181269ICertaintyRfpi
K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited
K152930PeriFlux6000PERIMED AB
K150347Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+DELTEX MEDICAL LIMITED
K150268CerOXOR-NIM MEDICAL LTD.

Global Unique Device Identification Database

00634782553173Flowmeter, Blood, Cardiovascular
50699753450399Flowmeter, Blood, Cardiovascular
00817122020454FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020409FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020393FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020386FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020379FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020362FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020355FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020348FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020324FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020140FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020133FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020126FLOWMETER, BLOOD, CARDIOVASCULAR
00817122020119FLOWMETER, BLOOD, CARDIOVASCULAR

Maude Adverse Events

FLOW COUPLERBAXTER HEALTHCARE CORPORATION2020-03-10
DOPPLER PROBE2019-07-23
TRANSONICTRANSONIC SYSTEMS INC.2019-07-10
CO-SET KITEDWARDS LIFESCIENCES, LLC2019-06-21
FLOWMETER, BLOOD, CARDIOVASCULARPARKS MEDICAL ELECTRONICS, INC.2017-10-05
CO-SET+ DELIVERY SYSTEM (CARDIAC OUTPUT TUBING AND SYRINGE)EDWARDS LIFESCIENCES2017-05-25
CO-SET; CO-SET+CLOSED INJECTATE SYSTEMEDWARDS LIFESCIENCES LLC2016-07-11
HEART-LUNG MACHINE HL20MAQUET CARDIOPULMONARY AG2015-08-03
HL-20 TWIN PUMPMAQUET CARDIOPULMONARY AG2015-07-28
HL-20 TWIN PUMPMAQUET CARDIOPULMONARY AG2015-07-28
HL-20 TWIN PUMPMAQUET CARDIOPULMONARY AG2015-07-28
HL-20 TWIN PUMPMAQUET CARDIOPULMONARY AG2015-07-28
MAQUET CARDIOPULMONARY AGMAQUET CARDIOPULMONARY AG2015-07-13
MAQUET CARDIOPULMONARY AGMAQUET CARDIOPULMONARY AG2015-05-22
GEM FLOW COUPLER DEVICE AND SYSTEMSYNOVIS SURGICAL INNOVATIONS2015-04-10
MAQUET CARDIOPULMONARY AGMAQUET CARDIOPULMONARY AG2015-03-18
MAQUET VARIO TWIN, HL 20, 4-PUMPSMAQUET CARDIOPULMONARY AG2015-03-18
SINGLE ROLLER PUMP MODULEMAQUET CARDIOPULMONARY AG2015-02-26
MAQUET HL20 TWIN PUMPMAQUET CARDIOPULMONARY AG2015-02-03
MAQUET HL-20 TWIN PUMPMAQUET CARDIOPULMOARY AG2014-11-26
MAQUET HL-20 TWIN PUMPMAQUET CARDIOPULMOARY AG2014-11-26
MAQUET HL-20 TWIN PUMPMAQUET CARDIOPULMOARY AG2014-11-26
MAQUET HL-20 TWIN PUMPMAQUET CARDIOPULMOARY AG2014-11-26
MAQUET HL-20 TWIN PUMPMAQUET CARDIOPULMOARY AG2014-11-26
MAQUET HL20 TWIN PUMPMAQUET CARDIOPULMONARY AG2014-11-07
EDWARDS CO-SET+EDWARDS LIFESCIENCES AG2014-07-18
MAQUET CARDIOPULMONARY AGMAQUET CARDIOPULMONARY AG2013-10-08
MAQUET CARDIOPULMONARY AGMAQUET CARDIOPULMONARY AG2013-10-08
MAQUET CARDIOPULMONARY AGMAQUET CARDIOPULMONARY AG2013-08-26
MEDI-STIM QUICK FIT PROBEMEDISTIM USA INC.2011-12-29
MEDI-STIM QUICKFIT PROBEMEDISTIM USA2011-12-29
HEMEDEX QFLOW 500 PROBEHEMEDEX2009-07-29
NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XLINTEGRA NEUROSCIENCES2005-09-15
NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XLINTEGRA NEUROSCIENCES2005-09-15
NEUROSENSOR COMBINED ICB/CBF PARACH PROBEINTEGRA NEUROSCIENCES2005-09-15
NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XLINTEGRA NEURO SCIENCES2005-09-14
NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XLINTEGRA NEUROSCIENCES2005-09-14
NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XLINTEGRA NEURO SCIENCES2005-09-09
NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XLINTEGRA NEURO SCIENCES2005-09-09
NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XLINTEGRA NEURO SCIENCES2005-09-09
NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XINTEGRA NEURO SCIENCES2005-07-08
QUANTIX/ORCARDIOSONIX, LTD.2004-12-02
ODP/EDM PROBEDELTEX MEDICAL LTD2003-11-07
LASERFLOVASAMEDICS2001-04-05
SURETYTHE KENDALL COMPANY2000-11-30
ARROW HEMOSONIC 100 SYSTEMARROW INTERNATIONAL, INC.2000-07-28
LASERFLOVASAMEDICS L.L.C.1997-03-17
BOOD FLOW METERTRANSONIC SYSTEMS, INC.1996-11-15
TRANSONIC SYSTEMS TRANSIT TIME FLOWMETERTRANSONIC SYSTEMS, INC.1996-08-30
CARDIAC OUTPUT BRIDGECOBE CARDIOVASCULAR, INC.1995-04-17
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