Cleared Traditional

MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151

K080924 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular
Apr 2008
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K080924 is an FDA 510(k) clearance for the MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151, a Stylet, Catheter (Class II — Special Controls, product code DRB), submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on April 30, 2008, 28 days after receiving the submission on April 2, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1380.

Submission Details

510(k) Number K080924 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2008
Decision Date April 30, 2008
Days to Decision 28 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