FDA 510(k)

Sistema de Fio Periférico Desmontável AZUR CX 18

Número K: K162524 · 2017-03-03

Data da decisão2017-03-03

Código do produtoKRD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AZUR CX Detachable 18 Peripheral 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 2017-03-03 under 510(k) number K162524. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is MicroVention, Inc.. The 510(k) number is K162524.

When did AZUR CX Detachable 18 Peripheral Coil System receive FDA 510(k) clearance?

AZUR CX Detachable 18 Peripheral Coil System received FDA 510(k) clearance on 2017-03-03, under 510(k) number K162524.

Who is the listed applicant for AZUR CX Detachable 18 Peripheral 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 CX Detachable 18 Peripheral Coil System?

The FDA product code for AZUR CX Detachable 18 Peripheral Coil System is KRD.

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Outros registros que listam MicroVention, Inc. como candidato(a)

K232542Wedge XL Delivery Catheter K230775SOFIA EX Intracranial Support Catheter K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)K222115ISAAC Neurovascular Navigation Catheter K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)K214024SOFIA 88 Catheter

Ver todos os 24 dispositivos →

Dispositivos Relacionados (Código: KRD)

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation K261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

Fonte oficial

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