FDA 510(k)

Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set

N.º K: K243601 · 2025-05-19

Fecha de decisión2025-05-19

Código de productoNRY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K243601. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set?

Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K243601.

When did Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set receive FDA 510(k) clearance?

Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set received FDA 510(k) clearance on 2025-05-19, under 510(k) number K243601.

Who is the listed applicant for Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set?

The FDA 510(k) record lists Route 92 Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set?

The FDA product code for Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is NRY.

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Otros registros que enlistan a Route 92 Medical, Inc. como solicitante

K260220Route 92 Medical Full Length 046 Access System K2405298F Sistema de Manguito Modificado K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set K231583Route 92 Medical Full Length 054 Access System K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set K222743Route 92 Medical Full Length 070 Access System

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Dispositivos relacionados (Código: NRY)

K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing KitMaduro Medical, Inc.K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd.K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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