Medical Device Manufacturer · US , South Jordan , UT

Merit Medical Systems, Inc. - FDA 510(k) Cleared Devices

180 submissions · 172 cleared · Since 1988
180
Total
172
Cleared
0
Denied
118 devices
101-118 of 118
Cleared Feb 27, 1998
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
K974067 · QEY
Cardiovascular · 123d
Cleared Dec 19, 1997
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
K973708 · DQX
Cardiovascular · 81d
Cleared Nov 25, 1997
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230 · DXT
Cardiovascular · 90d
Cleared Apr 15, 1997
CONTINUOUS FLUSH DEVICE
K962129 · KRA
Cardiovascular · 316d
Cleared Feb 10, 1995
MONARCH AP(TM)
K943597 · MAV
Cardiovascular · 202d
Cleared Mar 23, 1994
CHECK VALVE (FITTING)
K933084 · DTL
Cardiovascular · 273d
Cleared Mar 15, 1994
TORQUE DEVICE
K936032 · DQX
Cardiovascular · 88d
Cleared Nov 23, 1993
STOPCOCK (ONE-PORT MANIFOLD)
K934123 · DTL
Cardiovascular · 90d
Cleared Aug 05, 1993
ROTATOR
K932251 · DTR
Cardiovascular · 87d
Cleared Jan 22, 1993
PASSAGE HEMOSTASIS VALVE
K925419 · DTL
Cardiovascular · 87d
Cleared Dec 11, 1992
MERITRANS(TM) DISPOSABLE TRANSDUCER
K920977 · DRS
Cardiovascular · 284d
Cleared Sep 21, 1992
MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI
K921702 · DQX
Cardiovascular · 164d
Cleared Feb 04, 1992
MONARCH(TM) INFLATION SYRINGE
K913994 · MAV
Cardiovascular · 151d
Cleared Dec 18, 1991
MERIT DISPOSAL DEPOT(TM)
K914208 · DQO
Cardiovascular · 90d
Cleared Nov 15, 1991
MERIT CUSTOM KIT
K913682 · DQO
Cardiovascular · 88d
Cleared Oct 21, 1991
MERIT MANIFOLD
K913161 · DTL
Cardiovascular · 96d
Cleared Apr 18, 1989
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
K884913 · DXT
Cardiovascular · 141d
Cleared Feb 11, 1988
DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196 · DXT
Cardiovascular · 56d

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