Cleared Traditional

INTRALUMINAL ARTERY STRIPPER

K913803 · Omni-Tract Surgical, Div. Minn. Scientific, Inc. · Cardiovascular

Apr 1992

Decision

242d

Days

Class 2

Risk

About This 510(k) Submission

K913803 is an FDA 510(k) clearance for the INTRALUMINAL ARTERY STRIPPER, a Stripper, Artery, Intraluminal (Class II — Special Controls, product code DWX), submitted by Omni-Tract Surgical, Div. Minn. Scientific, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 24, 1992, 242 days after receiving the submission on August 26, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number	K913803 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 1991
Decision Date	April 24, 1992
Days to Decision	242 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement