FDA 510(k)

SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)

N.º K: K241207 · 2024-05-29

Fecha de decisión2024-05-29

Código de productoQEW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) is the device name listed in this FDA 510(k) record. The listed applicant is Devoro Medical, Inc.. It received FDA 510(k) clearance on 2024-05-29 under 510(k) number K241207. 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 SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)?

SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Devoro Medical, Inc.. The 510(k) number is K241207.

When did SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) receive FDA 510(k) clearance?

SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) received FDA 510(k) clearance on 2024-05-29, under 510(k) number K241207.

Who is the listed applicant for SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)?

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

What is the FDA product code for SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)?

The FDA product code for SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) is QEW.

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Otros registros que enlistan a Devoro Medical, Inc. como solicitante

K221391WOLF Thrombectomy™ SmartClaw Catheter K210911WOLF Thrombectomy System, 14F K210530WOLF Thrombectomy System, 6F K200101WOLF Thrombectomy V System

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.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.

Fuente oficial

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