FDA 510(k)

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device

N.º K: K230429 · 2023-04-17

Fecha de decisión2023-04-17

Código de productoNRY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Medical , Ltd.. It received FDA 510(k) clearance on 2023-04-17 under 510(k) number K230429. 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 Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device?

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device is a medical device that received FDA 510(k) clearance on 2023-04-17. The listed applicant is Rapid Medical , Ltd.. The 510(k) number is K230429.

When did Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device receive FDA 510(k) clearance?

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device received FDA 510(k) clearance on 2023-04-17, under 510(k) number K230429.

Who is the listed applicant for Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device?

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

What is the FDA product code for Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device?

The FDA product code for Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device is NRY.

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Otros registros que enlistan a Rapid Medical , Ltd. como solicitante

K253146Hyperdrive 35 Guidewire K260617Tigertriever 13 Ultra Revascularization Device K254006Drivewire 35 Guidewire K253062Tigertriever 25 Revascularization Device K251603Tigertriever 17 Ultra Revascularization Device K233791Drivewire 24 Guidewire

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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.