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FDA 510(k)

Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)

K-Number: K153460 · 2016-03-01

ApplicantAvinger, Inc.
Decision Date2016-03-01
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) is a medical device manufactured by Avinger, Inc.. It received FDA 510(k) clearance on 2016-03-01 under approval number K153460. 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 (8Fr), Pantheris Catheter (7Fr)?

Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) is a medical device that received FDA 510(k) clearance on 2016-03-01. It is manufactured by Avinger, Inc.. The 510(k) number is K153460.

When was Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) approved by the FDA?

Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) received FDA 510(k) clearance on 2016-03-01, under approval number K153460.

What company makes Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)?

Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) is manufactured by Avinger, Inc..

What is the FDA product code for Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)?

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

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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. 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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