FDA 510(k)

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

N.º K: K233708 · 2024-02-16

Fecha de decisión2024-02-16

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) is the device name listed in this FDA 510(k) record. The listed applicant is Synaptic Medical Corporation. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K233708. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)?

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Synaptic Medical Corporation. The 510(k) number is K233708.

When did NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) receive FDA 510(k) clearance?

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) received FDA 510(k) clearance on 2024-02-16, under 510(k) number K233708.

Who is the listed applicant for NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)?

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

What is the FDA product code for NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)?

The FDA product code for NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) is DYB.

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Otros registros que enlistan a Synaptic Medical Corporation como solicitante

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Dispositivos relacionados (Código: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

Fuente oficial

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