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)

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System

K-Number: K172386 · 2017-08-24

ApplicantVolcano Atheromed, Inc.
Decision Date2017-08-24
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System is a medical device manufactured by Volcano Atheromed, Inc.. It received FDA 510(k) clearance on 2017-08-24 under approval number K172386. 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 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System?

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System is a medical device that received FDA 510(k) clearance on 2017-08-24. It is manufactured by Volcano Atheromed, Inc.. The 510(k) number is K172386.

When was 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System approved by the FDA?

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System received FDA 510(k) clearance on 2017-08-24, under approval number K172386.

What company makes 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System?

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System is manufactured by Volcano Atheromed, Inc..

What is the FDA product code for 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System?

The FDA product code for 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System is MCW.

Related Clinical Trials

NCT04229563 Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease COMPLETED NCT07105930 Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach RECRUITING

Other Devices by Volcano Atheromed, Inc.

K182972Phoenix Atherectomy System K181877Phoenix 2.4mm Atherectomy Plus System K193197QuickClear Mechanical Thrombectomy System K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System

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.

↑