Medical Device Manufacturer · US , South Jordan , UT

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

177 submissions · 169 cleared · Since 1988
177
Total
169
Cleared
0
Denied
116 devices
51-75 of 116
Cleared Oct 16, 2014
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
K140543 · DYB
Cardiovascular · 226d
Cleared Sep 12, 2014
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
K140608 · DQX
Cardiovascular · 186d
Cleared Jul 09, 2014
MERIT SAFETY INTRODUCER NEEDLE
K140513 · DYB
Cardiovascular · 131d
Cleared Apr 16, 2014
ROTATING ADAPTERS
K140475 · DTL
Cardiovascular · 49d
Cleared Feb 12, 2014
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
K132720 · DYB
Cardiovascular · 166d
Cleared Dec 12, 2013
INQWIRE DIAGNOSTIC GUIDE WIRE
K133230 · DQX
Cardiovascular · 52d
Cleared Nov 07, 2013
Merit ASAPLP Aspiration Catheter
K132155 · QEZ
Cardiovascular · 118d
Cleared Sep 17, 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · DYB
Cardiovascular · 67d
Cleared Aug 29, 2013
CONCIERGE GUIDING CATHETER
K132409 · DQY
Cardiovascular · 27d
Cleared Jul 29, 2013
MERIT HYDROPHILIC GUIDE WIRE
K131710 · DQX
Cardiovascular · 48d
Cleared Jun 19, 2013
BASIXTOUCH
K130566 · MAV
Cardiovascular · 107d
Cleared Jun 07, 2013
PRELUDE SHEATH INTRODUCER
K130791 · DRE
Cardiovascular · 77d
Cleared Apr 05, 2013
MERIT HYDROPHILIC GUIDE WIRE
K130588 · DQX
Cardiovascular · 29d
Cleared Jan 16, 2013
MERIT HYDROPHILIC GUIDE WIRE
K123609 · DQX
Cardiovascular · 56d
Cleared Dec 05, 2012
MERIT ONE SNARE SYSTEM
K122088 · MMX
Cardiovascular · 142d
Cleared Sep 21, 2012
OSTIAL PRO STENT POSITIONING SYSTEM
K122089 · DQX
Cardiovascular · 67d
Cleared Sep 19, 2012
MERIT HYDROPHILIC GUIDE WIRE
K120644 · DQX
Cardiovascular · 201d
Cleared Aug 17, 2012
PRELUDE 7F SHORT SHEATH INTRODUCER
K122190 · DYB
Cardiovascular · 24d
Cleared Jun 13, 2012
CONCIERGE GUIDING CATHETER
K121051 · DQY
Cardiovascular · 68d
Cleared Jul 01, 2011
MERIT MARQUIS FLOW SWITCH
K110643 · DQO
Cardiovascular · 119d
Cleared Mar 11, 2011
MERIT EMBOLECTOMY CATHETER MODEL ASAP100
K100569 · QEZ
Cardiovascular · 375d
Cleared Apr 28, 2010
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R
K100319 · DTL
Cardiovascular · 83d
Cleared Feb 12, 2010
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING
K093004 · DQO
Cardiovascular · 137d
Cleared Oct 27, 2009
MERIT LAUREATE HYDROPHILIC GUIDE WIRE
K092303 · DQX
Cardiovascular · 90d
Cleared Oct 09, 2009
MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
K091584 · DRE
Cardiovascular · 129d

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