Cleared Traditional

ENDOHELIX ENDARTERECTOMY DEVICE

K032105 · Endarx, Inc. · Cardiovascular

Oct 2003

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K032105 is an FDA 510(k) clearance for the ENDOHELIX ENDARTERECTOMY DEVICE, a Stripper, Artery, Intraluminal (Class II — Special Controls, product code DWX), submitted by Endarx, Inc. (Portola Valley, US). The FDA issued a Cleared decision on October 30, 2003, 114 days after receiving the submission on July 8, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number	K032105 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2003
Decision Date	October 30, 2003
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF