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)

Gallant PTCA Dilatation Catheter

K-Number: K173581 · 2018-01-25

ApplicantMedinol, Ltd.
Decision Date2018-01-25
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Gallant PTCA Dilatation Catheter is a medical device manufactured by Medinol, Ltd.. It received FDA 510(k) clearance on 2018-01-25 under approval number K173581. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gallant PTCA Dilatation Catheter?

Gallant PTCA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2018-01-25. It is manufactured by Medinol, Ltd.. The 510(k) number is K173581.

When was Gallant PTCA Dilatation Catheter approved by the FDA?

Gallant PTCA Dilatation Catheter received FDA 510(k) clearance on 2018-01-25, under approval number K173581.

What company makes Gallant PTCA Dilatation Catheter?

Gallant PTCA Dilatation Catheter is manufactured by Medinol, Ltd..

What is the FDA product code for Gallant PTCA Dilatation Catheter?

The FDA product code for Gallant PTCA Dilatation Catheter is LOX.

Related Clinical Trials

NCT07397390 an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions ENROLLING_BY_INVITATION NCT05509296 Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease COMPLETED

Other Devices by Medinol, Ltd.

K150487X-Suit NIR Biliary Metallic Stent K162434NC Gallant PTCA Catheter PMA P110004STENT, CORONARY PMA P170008Coronary drug-eluting stent

Related Devices (Code: LOX)

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation K160985Pantera ProBiotronik, Inc. K162209Sapphire NC PlusOrbusneich Medical, Inc. K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited

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.

↑