Cleared Traditional

MOLLRING CUTTER

K950813 · Cardio Vascular Concepts, Inc. · Cardiovascular

Jul 1995

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K950813 is an FDA 510(k) clearance for the MOLLRING CUTTER, a Stripper, Artery, Intraluminal (Class II — Special Controls, product code DWX), submitted by Cardio Vascular Concepts, Inc. (Portola Valley, US). The FDA issued a Cleared decision on July 25, 1995, 153 days after receiving the submission on February 22, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number	K950813 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 1995
Decision Date	July 25, 1995
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF