FDA 510(k)

Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled

Número K: K162326 · 2016-10-18

Data da decisão2016-10-18

Código do produtoMCW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled is the device name listed in this FDA 510(k) record. The listed applicant is Avinger, Inc.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162326. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled?

Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Avinger, Inc.. The 510(k) number is K162326.

When did Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled receive FDA 510(k) clearance?

Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162326.

Who is the listed applicant for Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled?

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

What is the FDA product code for Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled?

The FDA product code for Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled is MCW.

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Fonte oficial

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