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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 the device name listed in this FDA 510(k) record. The listed applicant is Medinol, Ltd.. It received FDA 510(k) clearance on 2018-01-25 under 510(k) 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. The listed applicant is Medinol, Ltd.. The 510(k) number is K173581.

When did Gallant PTCA Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Gallant PTCA Dilatation Catheter?

The FDA 510(k) record lists Medinol, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medinol, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P170008Coronary drug-eluting stentPMA P110004STENT, CORONARYK162434NC Gallant PTCA CatheterK150487X-Suit NIR Biliary Metallic Stent

Related Devices (Code: LOX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

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.

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