Cleared Traditional

K130633 - INTRODUCER SETS, MODEL ADELANTE RADIAL
(FDA 510(k) Clearance)

K130633 · Oscor, Inc. · Cardiovascular
Feb 2014
Decision
339d
Days
Class 2
Risk

K130633 is an FDA 510(k) clearance for the INTRODUCER SETS, MODEL ADELANTE RADIAL, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on February 13, 2014, 339 days after receiving the submission on March 11, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K130633 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2013
Decision Date February 13, 2014
Days to Decision 339 days
Submission Type Traditional
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