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FDA 510(k)

MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER

K-Number: K023223 · 2002-10-24

ApplicantLumend, Inc.
Decision Date2002-10-24
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Lumend, Inc.. It received FDA 510(k) clearance on 2002-10-24 under 510(k) number K023223. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER?

MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER is a medical device that received FDA 510(k) clearance on 2002-10-24. The listed applicant is Lumend, Inc.. The 510(k) number is K023223.

When did MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER receive FDA 510(k) clearance?

MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER received FDA 510(k) clearance on 2002-10-24, under 510(k) number K023223.

Who is the listed applicant for MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER?

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

What is the FDA product code for MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER?

The FDA product code for MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER is DQY.

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Other records listing Lumend, Inc. 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.

K043534MODIFICATION TO OUTBACK CATHETERK040771MODIFICATION TO OUTBACK CATHETERK033535LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIESK032298MODIFICATION TO OUTBACK CATHETERK031005LUMEND FRONTRUNNER GW CTO CATHETERK023114LUMEND FRONTRUNNER CTO CATHETER

View all 11 devices →

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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