Endohelix Endarterectomy Device

FDA 510(k) K032105 · Endarx, Inc.

Substantially Equivalent

510(k) numberK032105

Submission

Device name
Endohelix Endarterectomy Device
Applicant
Endarx, Inc.
Portola Valley, CA, US
Received
July 8, 2003
Decision date
October 30, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DWX – Stripper, Artery, Intraluminal
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4875
Specialty
Cardiovascular

Other 510(k)s with product code DWX

510(k)DeviceApplicantDecision
K121415Mollring MultitascDWX · Traditional LeMaitre Vascular, Inc.09/05/2012SE
K020925Carbodissecting EndoscopeDWX · Traditional Endo Surgical Devices, Inc.04/29/2003SE
K003719Vascular Architects Periscope DeviceDWX · Traditional Vascular Architects, Inc.02/28/2001SE
K950813Mollring CutterDWX · Traditional Cardio Vascular Concepts, Inc.07/25/1995SE
K933498External Vein StripperDWX · Traditional Applied Medical Resources03/23/1994SE
K913803Intraluminal Artery StripperDWX · Traditional Omni-Tract Surgical, Div. Minn. Scientific, Inc.04/24/1992SE
K911099Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional Pilling Co.06/25/1991SE
K904944Transluminal Endarterectomy DeviceDWX · Traditional Baxter Healthcare Corp12/17/1990SE
K895878Olympus Valvulotome W/Detachable TipDWX · Traditional Olympus Corp.01/02/1990SE
K894496Olympus Valvulotome W/Fixed TipDWX · Traditional Olympus Corp.10/12/1989SE

Questions and answers

When was Endohelix Endarterectomy Device cleared by the FDA?

Endohelix Endarterectomy Device (K032105) received a 510(k) decision of Substantially Equivalent on October 30, 2003, 114 days after the submission was received.

What is the product code of K032105?

The FDA product code is DWX – Stripper, Artery, Intraluminal, a Class II (moderate risk) device regulated under 21 CFR 870.4875.