FDA 510(k)

INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK

N.º K: K251949 · 2026-02-05

Fecha de decisión2026-02-05

Código de productoQEW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2026-02-05 under 510(k) number K251949. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK?

INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK is a medical device that received FDA 510(k) clearance on 2026-02-05. The listed applicant is Penumbra, Inc.. The 510(k) number is K251949.

When did INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK receive FDA 510(k) clearance?

INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK received FDA 510(k) clearance on 2026-02-05, under 510(k) number K251949.

Who is the listed applicant for INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK?

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

What is the FDA product code for INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK?

The FDA product code for INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK is QEW.

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Otros registros que enlistan a Penumbra, Inc. como solicitante

K250690Penumbra System (Thunderbolt Aspiration Tubing)K260599INDIGO® Aspiration System – INDIGO Link K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing K250079Ruby XL System K242104Penumbra System (Reperfusion Catheter RED 72)K242033Access25® Catéter de Microcatheter para Entrega

Ver todos los 60 dispositivos →

Dispositivos relacionados (Código: QEW)

K253419Triever Duo CatheterInari Medical, Inc.K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ Thrombectomy SystemJupiter Endovascular K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.