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)

Tigereye CTO-Crossing Catheter

K-Number: K201330 · 2020-09-10

ApplicantAvinger, Inc.
Decision Date2020-09-10
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tigereye CTO-Crossing Catheter is a medical device manufactured by Avinger, Inc.. It received FDA 510(k) clearance on 2020-09-10 under approval number K201330. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tigereye CTO-Crossing Catheter?

Tigereye CTO-Crossing Catheter is a medical device that received FDA 510(k) clearance on 2020-09-10. It is manufactured by Avinger, Inc.. The 510(k) number is K201330.

When was Tigereye CTO-Crossing Catheter approved by the FDA?

Tigereye CTO-Crossing Catheter received FDA 510(k) clearance on 2020-09-10, under approval number K201330.

What company makes Tigereye CTO-Crossing Catheter?

Tigereye CTO-Crossing Catheter is manufactured by Avinger, Inc..

What is the FDA product code for Tigereye CTO-Crossing Catheter?

The FDA product code for Tigereye CTO-Crossing Catheter is PDU.

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: PDU)

K162418Pioneer Plus CatheterPhilips Volcano K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc K183357XableCath Crossing CatheterXablecath, Inc. K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc. K203363Crosser iQ CTO Recanalization SystemC.R. Bard, 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.

↑