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FDA 510(k)

ENDOHELIX ENDARTERECTOMY DEVICE

K-Number: K032105 · 2003-10-30

ApplicantEndarx, Inc.
Decision Date2003-10-30
Product CodeDWX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENDOHELIX ENDARTERECTOMY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Endarx, Inc.. It received FDA 510(k) clearance on 2003-10-30 under 510(k) number K032105. The device is classified under product code DWX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOHELIX ENDARTERECTOMY DEVICE?

ENDOHELIX ENDARTERECTOMY DEVICE is a medical device that received FDA 510(k) clearance on 2003-10-30. The listed applicant is Endarx, Inc.. The 510(k) number is K032105.

When did ENDOHELIX ENDARTERECTOMY DEVICE receive FDA 510(k) clearance?

ENDOHELIX ENDARTERECTOMY DEVICE received FDA 510(k) clearance on 2003-10-30, under 510(k) number K032105.

Who is the listed applicant for ENDOHELIX ENDARTERECTOMY DEVICE?

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

What is the FDA product code for ENDOHELIX ENDARTERECTOMY DEVICE?

The FDA product code for ENDOHELIX ENDARTERECTOMY DEVICE is DWX.

Related Clinical Trials

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Related Devices (Code: DWX)

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.

K121415MOLLRING MULTITASCLeMaitre Vascular, Inc.K020925CARBODISSECTING ENDOSCOPEEndo Surgical Devices, Inc.K003719VASCULAR ARCHITECTS PERISCOPE DEVICEVascular Architects, Inc.K950813MOLLRING CUTTERCardio Vascular Concepts, Inc.K933498EXTERNAL VEIN STRIPPERApplied Medical ResourcesK913803INTRALUMINAL ARTERY STRIPPEROmni-Tract Surgical, Div. Minn. Scientific, Inc.

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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