Cleared Traditional

K905528 - URESIL VALVE CUTTER
(FDA 510(k) Clearance)

K905528 · Uresil Corp. · Cardiovascular
Apr 1991
Decision
129d
Days
Class 2
Risk

K905528 is an FDA 510(k) clearance for the URESIL VALVE CUTTER, a Stripper, Vein, External (Class II — Special Controls, product code DWQ), submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on April 18, 1991, 129 days after receiving the submission on December 10, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K905528 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1990
Decision Date April 18, 1991
Days to Decision 129 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DWQ — Stripper, Vein, External
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4885