Cleared Traditional

FIRSTSTIC N INTRODUCER

K141969 · Argon Medical Devices, Inc. · Cardiovascular
Dec 2014
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K141969 is an FDA 510(k) clearance for the FIRSTSTIC N INTRODUCER, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on December 19, 2014, 151 days after receiving the submission on July 21, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K141969 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2014
Decision Date December 19, 2014
Days to Decision 151 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

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