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 DETACHABLE 35 PLATINUM COIL SYSTEM

K-Number: K111307 · 2011-06-15

ApplicantMicroVention, Inc.
Decision Date2011-06-15
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AZUR DETACHABLE 35 PLATINUM COIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2011-06-15 under 510(k) number K111307. 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 DETACHABLE 35 PLATINUM COIL SYSTEM?

AZUR DETACHABLE 35 PLATINUM COIL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-15. The listed applicant is MicroVention, Inc.. The 510(k) number is K111307.

When did AZUR DETACHABLE 35 PLATINUM COIL SYSTEM receive FDA 510(k) clearance?

AZUR DETACHABLE 35 PLATINUM COIL SYSTEM received FDA 510(k) clearance on 2011-06-15, under 510(k) number K111307.

Who is the listed applicant for AZUR DETACHABLE 35 PLATINUM COIL SYSTEM?

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 DETACHABLE 35 PLATINUM COIL SYSTEM?

The FDA product code for AZUR DETACHABLE 35 PLATINUM COIL SYSTEM is KRD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K232542Wedge XL Delivery CatheterK230775SOFIA EX Intracranial Support CatheterK222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)K222115ISAAC Neurovascular Navigation CatheterK223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)K214024SOFIA 88 Catheter

View all 77 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.

↑