Cleared Special

DESTINO TWIST, STEERABLE GUIDING SHEATH

K140406 · Oscor, Inc. · Cardiovascular
Apr 2014
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K140406 is an FDA 510(k) clearance for the DESTINO TWIST, STEERABLE GUIDING SHEATH, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on April 17, 2014, 58 days after receiving the submission on February 18, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K140406 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2014
Decision Date April 17, 2014
Days to Decision 58 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340