FDA 510(k)

ACUNAV Luxera 4D ICE Catheter

N.º K: K261696 · 2026-09-10

SolicitanteSiemens Medical Solutions USA, Inc.

Fecha de decisión2026-09-10

Código de productoOBJ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACUNAV Luxera 4D ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K261696. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ACUNAV Luxera 4D ICE Catheter?

ACUNAV Luxera 4D ICE Catheter is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K261696.

When did ACUNAV Luxera 4D ICE Catheter receive FDA 510(k) clearance?

ACUNAV Luxera 4D ICE Catheter received FDA 510(k) clearance on 2026-09-10, under 510(k) number K261696.

Who is the listed applicant for ACUNAV Luxera 4D ICE Catheter?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUNAV Luxera 4D ICE Catheter?

The FDA product code for ACUNAV Luxera 4D ICE Catheter is OBJ.

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