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FDA 510(k)

SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON

K-Number: K103095 · 2010-10-22

ApplicantMedtronic, Ireland
Decision Date2010-10-22
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Ireland. It received FDA 510(k) clearance on 2010-10-22 under 510(k) number K103095. 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 SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON?

SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON is a medical device that received FDA 510(k) clearance on 2010-10-22. The listed applicant is Medtronic, Ireland. The 510(k) number is K103095.

When did SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON receive FDA 510(k) clearance?

SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON received FDA 510(k) clearance on 2010-10-22, under 510(k) number K103095.

Who is the listed applicant for SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON?

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

What is the FDA product code for SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON?

The FDA product code for SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON is LOX.

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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

View on FDA Database →

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

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