FDA 510(k)

Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200

N.º K: K183290 · 2019-02-25

Fecha de decisión2019-02-25

Código de productoQEY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 is the device name listed in this FDA 510(k) record. The listed applicant is Thrombolex, Inc.. It received FDA 510(k) clearance on 2019-02-25 under 510(k) number K183290. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200?

Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 is a medical device that received FDA 510(k) clearance on 2019-02-25. The listed applicant is Thrombolex, Inc.. The 510(k) number is K183290.

When did Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 receive FDA 510(k) clearance?

Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 received FDA 510(k) clearance on 2019-02-25, under 510(k) number K183290.

Who is the listed applicant for Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200?

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

What is the FDA product code for Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200?

The FDA product code for Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 is QEY.

Ensayos clínicos relacionados

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Otros registros que enlistan a Thrombolex, Inc. como solicitante

Dispositivos relacionados (Código: QEY)

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Fuente oficial

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