Cleared Traditional

INTRODUCER, MODEL ADELANTE MAGNUM

K140917 · Oscor, Inc. · Cardiovascular
Jul 2014
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K140917 is an FDA 510(k) clearance for the INTRODUCER, MODEL ADELANTE MAGNUM, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on July 9, 2014, 90 days after receiving the submission on April 10, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K140917 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2014
Decision Date July 09, 2014
Days to Decision 90 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