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FDA 510(k)

EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER

K-Number: K110133 · 2011-06-10

ApplicantCreganna-Tactx Medical
Decision Date2011-06-10
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Creganna-Tactx Medical. It received FDA 510(k) clearance on 2011-06-10 under 510(k) number K110133. 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 EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER?

EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2011-06-10. The listed applicant is Creganna-Tactx Medical. The 510(k) number is K110133.

When did EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER receive FDA 510(k) clearance?

EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER received FDA 510(k) clearance on 2011-06-10, under 510(k) number K110133.

Who is the listed applicant for EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER?

The FDA 510(k) record lists Creganna-Tactx Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER?

The FDA product code for EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER is LOX.

Related Clinical Trials

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.

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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

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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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