Cleared Traditional

EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.

K052965 · Guidant Corporation · Cardiovascular
Feb 2006
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K052965 is an FDA 510(k) clearance for the EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832., a Stylet, Catheter (Class II — Special Controls, product code DRB), submitted by Guidant Corporation (St. Paul, US). The FDA issued a Cleared decision on February 13, 2006, 115 days after receiving the submission on October 21, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1380.

Submission Details

510(k) Number K052965 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2005
Decision Date February 13, 2006
Days to Decision 115 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRB — Stylet, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1380