FDA 510(k)

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip

Número K: K160583 · 2016-10-26

Data da decisão2016-10-26

Código do produtoOBJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2016-10-26 under 510(k) number K160583. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip?

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip is a medical device that received FDA 510(k) clearance on 2016-10-26. The listed applicant is Volcano Corporation. The 510(k) number is K160583.

When did REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip receive FDA 510(k) clearance?

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip received FDA 510(k) clearance on 2016-10-26, under 510(k) number K160583.

Who is the listed applicant for REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip?

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

What is the FDA product code for REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip?

The FDA product code for REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip is OBJ.

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