DPW · Class II · 21 CFR 870.2100

FDA Product Code DPW: Flowmeter, Blood, Cardiovascular

Leading manufacturers include Koven Technology, Inc., Remington Medical, Inc. and Flosonics Medical.

138
Total
138
Cleared
165d
Avg days
1976
Since
138 devices
25–48 of 138
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 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 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 May 14, 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505
Terumo Cardiovascular Systems Corp.
Cardiovascular · 84d
Cleared Feb 12, 2002
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
K010452
Koven Technology, Inc.
Cardiovascular · 362d
Cleared Nov 17, 2000
TISSUE SPECTROSCOPE
K992529
Vital Medical , Ltd.
Cardiovascular · 478d
Cleared Aug 19, 1999
JOSTRA HL-20 TWIN PUMP
K984338
Jostra Bentley
Cardiovascular · 259d
Cleared Aug 03, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100
K992387
Rossmax International , Ltd.
Cardiovascular · 15d
Cleared Aug 03, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200
K992388
Rossmax International , Ltd.
Cardiovascular · 15d
Cleared May 20, 1999
WRIST BLOOD PRESSURE METER MODEL SE-330
K973078
Sein Electronics Co., Ltd.
Cardiovascular · 640d
Cleared Nov 24, 1998
TUBING BLOOD FLOW METER MODEL NUMBER HD-800
K982986
Koven Technology, Inc.
Radiology · 90d
Cleared Oct 14, 1998
VGF-7 VASCULAR GRAFT FLOWMETER
K973198
Medicard , Ltd.
Cardiovascular · 414d
Cleared May 28, 1998
PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
K974285
Perimed, Inc.
Cardiovascular · 195d