Cleared Special

INTRODUCER SET, MODEL ADELANTE-S SERIES

K122084 · Oscor, Inc. · Cardiovascular
Aug 2012
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K122084 is an FDA 510(k) clearance for the INTRODUCER SET, MODEL ADELANTE-S SERIES, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on August 29, 2012, 44 days after receiving the submission on July 16, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K122084 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2012
Decision Date August 29, 2012
Days to Decision 44 days
Submission Type Special
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