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FDA 510(k)

LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES

K-Number: K033535 · 2004-01-07

ApplicantLumend, Inc.
Decision Date2004-01-07
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Lumend, Inc.. It received FDA 510(k) clearance on 2004-01-07 under 510(k) number K033535. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES?

LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2004-01-07. The listed applicant is Lumend, Inc.. The 510(k) number is K033535.

When did LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES receive FDA 510(k) clearance?

LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES received FDA 510(k) clearance on 2004-01-07, under 510(k) number K033535.

Who is the listed applicant for LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES?

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 LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES?

The FDA product code for LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES is PDU.

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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 CATHETERK032298MODIFICATION TO OUTBACK CATHETERK031005LUMEND FRONTRUNNER GW CTO CATHETERK023114LUMEND FRONTRUNNER CTO CATHETERK023223MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER

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Related Devices (Code: PDU)

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.

K262013Kiba CTO Crossing CatheterReflow Medical, Inc.K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K251376LimFlow ARCLimFlow, Inc.K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.

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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