FDA 510(k)

OPTIS Metallic Stent Optimization E.4 SW

Número K: K160878 · 2016-06-29

Data da decisão2016-06-29

Código do produtoNQQ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

OPTIS Metallic Stent Optimization E.4 SW is the device name listed in this FDA 510(k) record. The listed applicant is Lightlab Imaging, Inc.. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K160878. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OPTIS Metallic Stent Optimization E.4 SW?

OPTIS Metallic Stent Optimization E.4 SW is a medical device that received FDA 510(k) clearance on 2016-06-29. The listed applicant is Lightlab Imaging, Inc.. The 510(k) number is K160878.

When did OPTIS Metallic Stent Optimization E.4 SW receive FDA 510(k) clearance?

OPTIS Metallic Stent Optimization E.4 SW received FDA 510(k) clearance on 2016-06-29, under 510(k) number K160878.

Who is the listed applicant for OPTIS Metallic Stent Optimization E.4 SW?

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

What is the FDA product code for OPTIS Metallic Stent Optimization E.4 SW?

The FDA product code for OPTIS Metallic Stent Optimization E.4 SW is NQQ.

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