FDA 510(k)

InZone IST Detachment System; IZDS Connecting Cable

Número K: K251832 · 2025-10-17

Data da decisão2025-10-17

Código do produtoHCG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

InZone IST Detachment System; IZDS Connecting Cable is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251832. 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 IST Detachment System; IZDS Connecting Cable?

InZone IST Detachment System; IZDS Connecting Cable is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Stryker Neurovascular. The 510(k) number is K251832.

When did InZone IST Detachment System; IZDS Connecting Cable receive FDA 510(k) clearance?

InZone IST Detachment System; IZDS Connecting Cable received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251832.

Who is the listed applicant for InZone IST Detachment System; IZDS Connecting Cable?

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 IST Detachment System; IZDS Connecting Cable?

The FDA product code for InZone IST Detachment System; IZDS Connecting Cable 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 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 K241637Echo Intracranial Base Catheter

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Dispositivos Relacionados (Código: HCG)

Fonte oficial

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