Cleared Traditional

ACUITY STEERABLE STYLET ACCESSORY

K053019 · Guidant Corporation · Cardiovascular
Mar 2006
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K053019 is an FDA 510(k) clearance for the ACUITY STEERABLE STYLET ACCESSORY, a Stylet, Catheter (Class II — Special Controls, product code DRB), submitted by Guidant Corporation (St. Paul, US). The FDA issued a Cleared decision on March 3, 2006, 128 days after receiving the submission on October 26, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1380.

Submission Details

510(k) Number K053019 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2005
Decision Date March 03, 2006
Days to Decision 128 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