Medical Device Manufacturer · US , Aliso Viejo , CA

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

85 submissions · 85 cleared · Since 2001

Recent clearances: Wedge XL Delivery Catheter, SOFIA EX Intracranial Support Catheter, EmPro EPS (EP4514C-190, EP6514C-190)

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85

Total

85

Cleared

0

Denied

FDA 510(k) Regulatory Record - MicroVention, Inc. Cardiovascular ✕

35 devices

1-12 of 35

Cleared CT Apr 27, 2023

EmPro EPS (EP4514C-190, EP6514C-190)

Cardiovascular · 233d

Cleared Dec 21, 2022

AZUR HydroPack 18 (45-880005

Cardiovascular · 83d

Cleared Mar 20, 2020

AZUR Vascular Plug

Cardiovascular · 270d

Cleared Apr 05, 2018

Wedge Microcatheter

Cardiovascular · 276d

Cleared Mar 03, 2017

AZUR CX Detachable 18 Peripheral Coil System

Cardiovascular · 175d

Cleared Dec 21, 2015

HydroPearl Microspheres, HydroPearl Microspheres

Cardiovascular · 264d

Cleared Sep 25, 2015

AZUR CX Detachable 35 Coils

Cardiovascular · 128d

Cleared Sep 17, 2015

LifePearl Microshperes

Cardiovascular · 161d

Cleared Mar 27, 2015

SOFIA 6F Catheter

Cardiovascular · 43d

Cleared Mar 26, 2015

Headway 27 Microcatheter

Cardiovascular · 205d

Cleared Oct 10, 2014

SOFIA DISTAL ACCESS CATHETER

Cardiovascular · 78d

Cleared Dec 20, 2013

AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35

Cardiovascular · 24d