Cleared Traditional

VASCULAR ARCHITECTS PERISCOPE DEVICE

K003719 · Vascular Architects, Inc. · Cardiovascular
Feb 2001
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K003719 is an FDA 510(k) clearance for the VASCULAR ARCHITECTS PERISCOPE DEVICE, a Stripper, Artery, Intraluminal (Class II — Special Controls, product code DWX), submitted by Vascular Architects, Inc. (San Jose, US). The FDA issued a Cleared decision on February 28, 2001, 86 days after receiving the submission on December 4, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K003719 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2000
Decision Date February 28, 2001
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWX — Stripper, Artery, Intraluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4875

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