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FDA 510(k)

Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

N.º K: K223530 · 2023-04-11

SolicitanteRoute 92 Medical, Inc.
Fecha de decisión2023-04-11
Código de productoNRY
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Route 92 Medical Full Length 070 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 2023-04-11 under 510(k) number K223530. 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 Full Length 070 Reperfusion System and Aspiration Tubing Set?

Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K223530.

When did Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set receive FDA 510(k) clearance?

Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set received FDA 510(k) clearance on 2023-04-11, under 510(k) number K223530.

Who is the listed applicant for Route 92 Medical Full Length 070 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 Full Length 070 Reperfusion System and Aspiration Tubing Set?

The FDA product code for Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is NRY.

Ensayos clínicos relacionados

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

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260220Route 92 Medical Full Length 046 Access SystemK243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetK2405298F Sistema de Manguito ModificadoK233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetK231583Route 92 Medical Full Length 054 Access SystemK222743Route 92 Medical Full Length 070 Access System

Ver todos los 14 dispositivos →

Dispositivos relacionados (Código: NRY)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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, LLCK260002Socrates 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.

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