Cleared Special

CATHETER INTRODUCER

K043525 · Galt Medical Corp. · Cardiovascular
Feb 2005
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K043525 is an FDA 510(k) clearance for the CATHETER INTRODUCER, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on February 9, 2005, 50 days after receiving the submission on December 21, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K043525 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2004
Decision Date February 09, 2005
Days to Decision 50 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