FDA 510(k)

Riptide Aspiration System

Número K: K243080 · 2024-10-29

RequerenteMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

Data da decisão2024-10-29

Código do produtoNRY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Riptide Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K243080. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Riptide Aspiration System?

Riptide Aspiration System is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K243080.

When did Riptide Aspiration System receive FDA 510(k) clearance?

Riptide Aspiration System received FDA 510(k) clearance on 2024-10-29, under 510(k) number K243080.

Who is the listed applicant for Riptide Aspiration System?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Riptide Aspiration System?

The FDA product code for Riptide Aspiration System is NRY.

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Outros registros que listam Micro Therapeutics, Inc. d/b/a ev3 Neurovascular como candidato(a)

K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter K243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing K211990Rist 071 Radial Access Guide Catheter K203432Axium Detachable Coil; Axium Prime Detachable Coil K203358Solitaire X Revascularization Device K202850Concerto Versa, Detachable Coil

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Dispositivos Relacionados (Código: NRY)

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Fonte oficial

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