Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) 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. The listed applicant is MicroVention, Inc.. The 510(k) number is K191680.

When did AZUR Vascular Plug receive FDA 510(k) clearance?

AZUR Vascular Plug received FDA 510(k) clearance on 2020-03-20, under 510(k) number K191680.

Who is the listed applicant for AZUR Vascular Plug?

The FDA 510(k) record lists MicroVention, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AZUR Vascular Plug?

The FDA product code for AZUR Vascular Plug is KRD.

Other records listing MicroVention, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P210030Stent, carotidPMA P170032Intrasaccular Flow Disruption DevicePMA P180027Intracranial aneurysm flow diverterK243638MV Flow Aspiration Pump (MVFLOWPMP01)PMA P170013Intracranial coil-assist stentK232542Wedge XL Delivery Catheter

View all 29 devices →

Related Devices (Code: KRD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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.

↑