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
26-50 of 116
Cleared Feb 15, 2018
Prelude IDeal Hydrophilic Sheath Introducer
K173750 · DYB
Cardiovascular · 69d
Cleared Dec 13, 2017
Advocate PTA Catheter
K173621 · LIT
Cardiovascular · 21d
Cleared Nov 30, 2017
HeRO Graft
K172637 · DSY
Cardiovascular · 90d
Cleared Sep 11, 2017
Prelude Pursuit Splittable Sheath Introducer
K172117 · DYB
Cardiovascular · 60d
Cleared Aug 04, 2017
Maestro Microcatheter
K172081 · KRA
Cardiovascular · 25d
Cleared Jul 21, 2017
True Form Reshapable Guide Wire
K170532 · DQX
Cardiovascular · 149d
Cleared Jun 22, 2017
Merit Hydrophilic Guide Wire
K170933 · DQX
Cardiovascular · 85d
Cleared Jun 15, 2017
Merit Coronary Control Syringe
K163084 · DXT
Cardiovascular · 224d
Cleared Apr 06, 2017
Inqwire Diagnostic Guide Wire
K170700 · DQX
Cardiovascular · 30d
Cleared Apr 05, 2017
HeartSpan Steerable Sheath Introducer
K170668 · DYB
Cardiovascular · 30d
Cleared Mar 03, 2017
Inqwire Diagnostic Guide Wire
K163575 · DQX
Cardiovascular · 74d
Cleared Jan 25, 2017
PreludeSYNC Radial Compression Device
K162988 · DXC
Cardiovascular · 90d
Cleared Nov 04, 2016
SwiftNINJA Microcatheter
K161921 · KRA
Cardiovascular · 114d
Cleared Oct 31, 2016
Squirt Fluid Delivery System
K162777 · QEY
Cardiovascular · 28d
Cleared Jul 29, 2016
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107 · DXT
Cardiovascular · 192d
Cleared Jan 20, 2016
basixTOUCH40 Inflation Syringe
K153672 · MAV
Cardiovascular · 30d
Cleared Oct 30, 2015
Prelude SNAP Splittable Hydrophilic Sheath Introducer
K152381 · DYB
Cardiovascular · 67d
Cleared Aug 27, 2015
5.5 F Worley Advanced LVI Lateral Vein Introducer
K152116 · DYB
Cardiovascular · 28d
Cleared Jul 01, 2015
EN Snare Endovascular Snare System
K151497 · MMX
Cardiovascular · 27d
Cleared Jun 19, 2015
PreludeEASE Hydrophilic Sheath Introducer
K150257 · DYB
Cardiovascular · 136d
Cleared Apr 09, 2015
Prelude SNAP Splittable Sheath Introducer
K143255 · DYB
Cardiovascular · 147d
Cleared Dec 22, 2014
Passage Hemostasis Valve
K143429 · DTL
Cardiovascular · 21d
Cleared Dec 17, 2014
PRELUDE PLASTIC JACKETED GUIDE WIRE
K142051 · DQX
Cardiovascular · 142d
Cleared Dec 16, 2014
MERIT HYDROPHILIC GUIDEWIRE
K141295 · DQX
Cardiovascular · 211d
Cleared Nov 13, 2014
ONE Snare Endovascular Microsnare System
K142265 · MMX
Cardiovascular · 90d

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