ENDOHELIX ENDARTERECTOMY DEVICE— 510(k) K032105

Substantially Equivalent

Endarx, Inc.

FDA 510(k) clearance K032105 for ENDOHELIX ENDARTERECTOMY DEVICE, Substantially Equivalent on 2003-10-30. Applicant: Endarx, Inc.. Device class: 2.

Clearance details

Applicant: Endarx, Inc.
Product code: Code DWX
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 2003-07-08
Decision date: 2003-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portola Valley, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.