Medical Device Manufacturer · US , Aliso Viejo , CA

MicroVention, Inc. - FDA 510(k) Cleared Devices

85 submissions · 85 cleared · Since 2001
85
Total
85
Cleared
0
Denied
85 devices
26-50 of 85
Cleared Dec 21, 2015
HydroPearl Microspheres, HydroPearl Microspheres
K150870 · KRD
Cardiovascular · 264d
Cleared Sep 25, 2015
AZUR CX Detachable 35 Coils
K151358 · KRD
Cardiovascular · 128d
Cleared Sep 17, 2015
LifePearl Microshperes
K150958 · KRD
Cardiovascular · 161d
Cleared Mar 27, 2015
SOFIA 6F Catheter
K150366 · DQY
Cardiovascular · 43d
Cleared Mar 26, 2015
Headway 27 Microcatheter
K142449 · DQY
Cardiovascular · 205d
Cleared Oct 10, 2014
SOFIA DISTAL ACCESS CATHETER
K142014 · DQY
Cardiovascular · 78d
Cleared Jul 31, 2014
TRAXCESS 14 GUIDEWIRE
K133725 · MOF
Neurology · 237d
Cleared Dec 20, 2013
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K133626 · KRD
Cardiovascular · 24d
Cleared Dec 19, 2013
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K132952 · HCG
Neurology · 91d
Cleared Nov 22, 2013
SOFIA DISTAL ACCESS CATHETER
K131482 · DQY
Cardiovascular · 183d
Cleared Oct 28, 2013
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
K132083 · KRD
Cardiovascular · 115d
Cleared Oct 04, 2013
MICROPLEX COIL SYSTEM (MCS)
K131948 · HCG
Neurology · 99d
Cleared Sep 20, 2013
MICROPLEX COIL SYSTEM (MCS), VFC
K132317 · HCG
Neurology · 57d
Cleared Jun 17, 2013
AZUR PUSHABLE 18 & 35 SYSTEM
K130577 · KRD
Cardiovascular · 104d
Cleared Nov 28, 2012
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL...
K122543 · KRD
Cardiovascular · 99d
Cleared Nov 28, 2012
AZUR CX DETACHABLE 18
K123384 · KRD
Cardiovascular · 26d
Cleared Aug 29, 2012
AZUR DETACHABLE 35
K122316 · KRD
Cardiovascular · 28d
Cleared Aug 10, 2012
SCEPTER C OCCLUSION BALLOON CATHETER
K121785 · MJN
Cardiovascular · 53d
Cleared Aug 02, 2012
HEADWAY DUO MICROCATHETER
K120917 · DQO
Cardiovascular · 128d
Cleared Apr 25, 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
K120908 · HCG
Neurology · 30d
Cleared Mar 28, 2012
AZUR DETACHABLE 18
K120630 · KRD
Cardiovascular · 27d
Cleared Jan 13, 2012
SCEPTER XC OCCLUSION BALLOON CATHETER
K113698 · MJN
Cardiovascular · 28d
Cleared Dec 16, 2011
HYDROCOIL EMBOLIC SYSTEM (HES)
K113457 · HCG
Neurology · 24d
Cleared Dec 01, 2011
HYDROCOIL(R) EMBOLIC SYSTEM (HES)
K112181 · HCG
Neurology · 126d
Cleared Sep 29, 2011
SCEPTER C OCCLUSION BALLOON CATHETER
K110741 · MJN
Cardiovascular · 197d

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