Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pantheris System

K-Number: K212047 · 2021-11-16

ApplicantAvinger, Inc.
Decision Date2021-11-16
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pantheris System is a medical device manufactured by Avinger, Inc.. It received FDA 510(k) clearance on 2021-11-16 under approval number K212047. 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 System?

Pantheris System is a medical device that received FDA 510(k) clearance on 2021-11-16. It is manufactured by Avinger, Inc.. The 510(k) number is K212047.

When was Pantheris System approved by the FDA?

Pantheris System received FDA 510(k) clearance on 2021-11-16, under approval number K212047.

What company makes Pantheris System?

Pantheris System is manufactured by Avinger, Inc..

What is the FDA product code for Pantheris System?

The FDA product code for Pantheris System 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.

↑