FDA 510(k)

The ICHOR Panacea Vascular Embolectomy Catheter System

N.º K: K182167 · 2018-12-21

Fecha de decisión2018-12-21

Código de productoQEW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

The ICHOR Panacea Vascular Embolectomy Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Ichor Vascular, Inc.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K182167. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the The ICHOR Panacea Vascular Embolectomy Catheter System?

The ICHOR Panacea Vascular Embolectomy Catheter System is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Ichor Vascular, Inc.. The 510(k) number is K182167.

When did The ICHOR Panacea Vascular Embolectomy Catheter System receive FDA 510(k) clearance?

The ICHOR Panacea Vascular Embolectomy Catheter System received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182167.

Who is the listed applicant for The ICHOR Panacea Vascular Embolectomy Catheter System?

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

What is the FDA product code for The ICHOR Panacea Vascular Embolectomy Catheter System?

The FDA product code for The ICHOR Panacea Vascular Embolectomy Catheter System is QEW.

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Fuente oficial

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