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FDA 510(k)

Pantheris SV

K-Number: K182341 · 2019-04-09

ApplicantAvinger, Inc.
Decision Date2019-04-09
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pantheris SV is a medical device manufactured by Avinger, Inc.. It received FDA 510(k) clearance on 2019-04-09 under approval number K182341. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pantheris SV?

Pantheris SV is a medical device that received FDA 510(k) clearance on 2019-04-09. It is manufactured by Avinger, Inc.. The 510(k) number is K182341.

When was Pantheris SV approved by the FDA?

Pantheris SV received FDA 510(k) clearance on 2019-04-09, under approval number K182341.

What company makes Pantheris SV?

Pantheris SV is manufactured by Avinger, Inc..

What is the FDA product code for Pantheris SV?

The FDA product code for Pantheris SV is MCW.

Other Devices by Avinger, Inc.

K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled K160827Pantheris Catheter K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled K173862Pantheris System

View all 12 devices →

Related Devices (Code: MCW)

K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledAvinger, Inc. K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. K160827Pantheris CatheterAvinger, Inc. K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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