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FDA 510(k)

OUTBACK CATHETER

K-Number: K001577 · 2001-01-11

ApplicantLumend, Inc.
Decision Date2001-01-11
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OUTBACK 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 2001-01-11 under 510(k) number K001577. 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 OUTBACK CATHETER?

OUTBACK CATHETER is a medical device that received FDA 510(k) clearance on 2001-01-11. The listed applicant is Lumend, Inc.. The 510(k) number is K001577.

When did OUTBACK CATHETER receive FDA 510(k) clearance?

OUTBACK CATHETER received FDA 510(k) clearance on 2001-01-11, under 510(k) number K001577.

Who is the listed applicant for OUTBACK 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 OUTBACK CATHETER?

The FDA product code for OUTBACK CATHETER is DQY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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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