FDA 510(k)

Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

Numéro K : K172236 · 2017-10-30

Date de décision2017-10-30

Code produitMCW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox 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 2017-10-30 under 510(k) number K172236. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled?

Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Avinger, Inc.. The 510(k) number is K172236.

When did Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled receive FDA 510(k) clearance?

Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled received FDA 510(k) clearance on 2017-10-30, under 510(k) number K172236.

Who is the listed applicant for Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox 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 (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled?

The FDA product code for Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled is MCW.

Essais cliniques associés

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Dispositifs connexes (Code : MCW)

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Source officielle

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