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FDA 510(k)

Pantheris Catheter

K-Number: K160827 · 2016-04-21

ApplicantAvinger, Inc.
Decision Date2016-04-21
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pantheris Catheter is a medical device manufactured by Avinger, Inc.. It received FDA 510(k) clearance on 2016-04-21 under approval number K160827. 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 Catheter?

Pantheris Catheter is a medical device that received FDA 510(k) clearance on 2016-04-21. It is manufactured by Avinger, Inc.. The 510(k) number is K160827.

When was Pantheris Catheter approved by the FDA?

Pantheris Catheter received FDA 510(k) clearance on 2016-04-21, under approval number K160827.

What company makes Pantheris Catheter?

Pantheris Catheter is manufactured by Avinger, Inc..

What is the FDA product code for Pantheris Catheter?

The FDA product code for Pantheris Catheter 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 K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled K173862Pantheris System K182341Pantheris SV

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. K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, Inc. K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox SledAvinger, 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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