Cleared Traditional

K080178 - VALVULOTOME BY KOVEN
(FDA 510(k) Clearance)

K080178 · Koven Technology, Inc. · Cardiovascular

Jul 2008

Decision

186d

Days

Class 2

Risk

K080178 is an FDA 510(k) clearance for the VALVULOTOME BY KOVEN, a Valvulotome (Class II — Special Controls, product code MGZ), submitted by Koven Technology, Inc. (Houston, US). The FDA issued a Cleared decision on July 28, 2008, 186 days after receiving the submission on January 24, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number	K080178 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2008
Decision Date	July 28, 2008
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF