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..

Clearance details

Applicant: Endarx, Inc.
Product code: Code DWX
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 ↗

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