FDA 510(k)

NC Gallant PTCA Catheter

K-Number: K162434 · 2017-01-19

Decision Date2017-01-19

Product CodeLOX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NC Gallant PTCA Catheter is a medical device manufactured by Medinol, Ltd.. It received FDA 510(k) clearance on 2017-01-19 under approval number K162434. 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 NC Gallant PTCA Catheter?

NC Gallant PTCA Catheter is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by Medinol, Ltd.. The 510(k) number is K162434.

When was NC Gallant PTCA Catheter approved by the FDA?

NC Gallant PTCA Catheter received FDA 510(k) clearance on 2017-01-19, under approval number K162434.

What company makes NC Gallant PTCA Catheter?

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

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

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

Other Devices by Medinol, Ltd.

K150487X-Suit NIR Biliary Metallic Stent K173581Gallant PTCA Dilatation Catheter PMA P110004STENT, CORONARY PMA P170008Coronary drug-eluting stent

Related Devices (Code: LOX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.