AZUR CX Detachable 18 Peripheral Coil System
K-Number: K162524 · 2017-03-03
ApplicantMicroVention, Inc.
Decision Date2017-03-03
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
AZUR CX Detachable 18 Peripheral Coil System is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2017-03-03 under approval number K162524. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AZUR CX Detachable 18 Peripheral Coil System?
AZUR CX Detachable 18 Peripheral Coil System is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by MicroVention, Inc.. The 510(k) number is K162524.
When was AZUR CX Detachable 18 Peripheral Coil System approved by the FDA?
AZUR CX Detachable 18 Peripheral Coil System received FDA 510(k) clearance on 2017-03-03, under approval number K162524.
What company makes AZUR CX Detachable 18 Peripheral Coil System?
AZUR CX Detachable 18 Peripheral Coil System is manufactured by MicroVention, Inc..
What is the FDA product code for AZUR CX Detachable 18 Peripheral Coil System?
The FDA product code for AZUR CX Detachable 18 Peripheral Coil System is KRD.
Related Clinical Trials
NCT06727942
Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes
RECRUITING
NCT04246281
The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain
COMPLETED
NCT07606196
The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases
COMPLETED
NCT05150197
Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease
RECRUITING
NCT00453505
Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System
COMPLETED
NCT04229563
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
COMPLETED
Related PubMed Literature
Other Devices by MicroVention, Inc.
K163154Traxcess 7 Mini XSoft Guidewire
K161803Traxcess .007 Mini Guidewire
K161367HydroCoil Embolic System (HES)
K161452MicroPlex Coil System (MCS) - HyperSoft 3D
K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
Related Devices (Code: KRD)
K162373LC Bead LUMIBiocompatibles UK Limited
K160219Hilal Embolization MicroCoilsCook Incorporated
K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated
K150876Bead BlockBiocompatibles UK , Ltd.
K171946Gel-BeadVascular Solutions, Inc.
K172372QuadraSphere MicrospheresBiosphere Medical, S.A.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.