FDA 510(k)

InZone Detachment System

Número K: K160096 · 2016-02-19

Data da decisão2016-02-19

Código do produtoHCG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

InZone Detachment System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K160096. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the InZone Detachment System?

InZone Detachment System is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Stryker Neurovascular. The 510(k) number is K160096.

When did InZone Detachment System receive FDA 510(k) clearance?

InZone Detachment System received FDA 510(k) clearance on 2016-02-19, under 510(k) number K160096.

Who is the listed applicant for InZone Detachment System?

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

What is the FDA product code for InZone Detachment System?

The FDA product code for InZone Detachment System is HCG.

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Outros registros que listam Stryker Neurovascular como candidato(a)

K261889Trevo Trak 21 Microcatheter K253032Cateter Intracraniano de Base AXS Lift K252694Target Detachable Coil K251832InZone IST Detachment System; IZDS Connecting Cable K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter K243593Cateter Intracraniano de Base AXS Lift

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Dispositivos Relacionados (Código: HCG)

Fonte oficial

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