Cleared Traditional

CO-AXIAL INTRODUCER NEEDLE

K022634 · Promex, Inc. · Cardiovascular
Nov 2002
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K022634 is an FDA 510(k) clearance for the CO-AXIAL INTRODUCER NEEDLE, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Promex, Inc. (Franklin, US). The FDA issued a Cleared decision on November 6, 2002, 90 days after receiving the submission on August 8, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K022634 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2002
Decision Date November 06, 2002
Days to Decision 90 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