AZUR Vascular Plug
K-Number: K191680 · 2020-03-20
ApplicantMicroVention, Inc.
Decision Date2020-03-20
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
AZUR Vascular Plug is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2020-03-20 under approval number K191680. 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 Vascular Plug?
AZUR Vascular Plug is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by MicroVention, Inc.. The 510(k) number is K191680.
When was AZUR Vascular Plug approved by the FDA?
AZUR Vascular Plug received FDA 510(k) clearance on 2020-03-20, under approval number K191680.
What company makes AZUR Vascular Plug?
AZUR Vascular Plug is manufactured by MicroVention, Inc..
What is the FDA product code for AZUR Vascular Plug?
The FDA product code for AZUR Vascular Plug is KRD.
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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
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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.