DPW · Class II · 21 CFR 870.2100

FDA Product Code DPW: Flowmeter, Blood, Cardiovascular

Leading manufacturers include Koven Technology, Inc., Transonic Systems, Inc. and Koven and Assoc., Inc..

139
Total
139
Cleared
165d
Avg days
1976
Since
139 devices
25–48 of 139
Cleared Oct 10, 2013
DELTEX MEDICAL CARDIOQ-EDM+
K132139
Deltex Medical Limited
Cardiovascular · 91d
Cleared Sep 13, 2013
CEROX
K131854
Or-Nim Medical , Ltd.
Cardiovascular · 84d
Cleared Jan 06, 2012
SONOTT FLOWLAB(R)
K111730
Em-Tec GmbH
Radiology · 200d
Cleared Dec 21, 2011
AUREFLO MONITORING SYSTEM
K112657
Transonic Systems, Inc.
Cardiovascular · 99d
Cleared Oct 20, 2011
DELTEX MEDICAL CARDIOQ EDM
K111542
Deltex Medical Limited
Cardiovascular · 140d
Cleared May 04, 2011
SENSILASE PAD-IQ
K110438
Vasamed, Inc.
Cardiovascular · 78d
Cleared Mar 16, 2011
DOPPLER MONITOR
K110347
Cook Vascular, Inc.
Radiology · 37d
Cleared Dec 27, 2010
MEDISTIM VERIQC SYSTEM
K102595
Medi-Stim Asa
Radiology · 109d
Cleared Nov 18, 2010
MOORVMS-PRES PRESSURE CUFF CONTROLLER
K102433
Moor Instruments, Ltd.
Cardiovascular · 84d
Cleared Oct 28, 2008
VTI INTRAOPERATIVE DOPPLER SYSTEMS
K082870
Vascular Technology Incorporated
Cardiovascular · 29d
Cleared Feb 28, 2007
CRITIVIEW, MODEL CRV3
K062977
Critisense , Ltd.
Cardiovascular · 152d
Cleared Jan 18, 2006
CRITIVIEW
K051145
Critisense , Ltd.
Cardiovascular · 259d
Cleared Sep 06, 2005
VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
K052209
Vascular Control Systems, Inc.
Cardiovascular · 22d
Cleared Apr 15, 2005
SMARTDOP 45 VASCULAR DOPPLER
K050601
Koven Technology, Inc.
Radiology · 37d
Cleared Feb 08, 2005
QUANTIX/OR BLOOD FLOW MONITOR
K050088
Neoprobe Corp.
Cardiovascular · 26d
Cleared Jun 07, 2004
QUANTIX OR VESSEL STABILIZER DEVICE
K041180
Cardiosonix, Ltd.
Cardiovascular · 32d
Cleared Jun 04, 2004
SENSILASE PAD 3000
K040654
Optical Sensors, Inc.
Cardiovascular · 84d
Cleared Apr 29, 2004
MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
K040228
Medi-Stim A/S
Cardiovascular · 87d
Cleared Apr 20, 2004
SONO TT ULTRASONIC FLOWCOMPUTER
K040909
Em-Tec GmbH
Cardiovascular · 12d
Cleared Feb 13, 2004
ECHO SOUNDER EX-101EX 8 MHZ
K031931
Koven Technology, Inc.
Cardiovascular · 235d
Cleared Dec 11, 2003
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
K033424
Transonic Systems, Inc.
Cardiovascular · 49d
Cleared Nov 25, 2003
MONITOR, MODEL HSM-00200
K031153
Arrow Intl., Inc.
Cardiovascular · 228d
Cleared Aug 20, 2003
QUANTIX/OR DEVICE
K030357
Cardiosonix, Ltd.
Cardiovascular · 198d
Cleared Aug 06, 2003
CARDIOQ, MODEL 9051-7005
K031706
Deltex Medical
Cardiovascular · 65d