Cleared Traditional

STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO

K120459 · Oscor, Inc. · Cardiovascular
Jun 2012
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K120459 is an FDA 510(k) clearance for the STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 29, 2012, 135 days after receiving the submission on February 15, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K120459 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 2012
Decision Date June 29, 2012
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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