Cleared Special

INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S

K073100 · Oscor, Inc. · Cardiovascular
Nov 2007
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K073100 is an FDA 510(k) clearance for the INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on November 30, 2007, 28 days after receiving the submission on November 2, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K073100 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2007
Decision Date November 30, 2007
Days to Decision 28 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