Cleared Traditional

STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078

K090163 · St Jude Medical · Cardiovascular
Apr 2009
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K090163 is an FDA 510(k) clearance for the STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078, a Stylet, Catheter (Class II — Special Controls, product code DRB), submitted by St Jude Medical (Sylamr, US). The FDA issued a Cleared decision on April 1, 2009, 69 days after receiving the submission on January 22, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1380.

Submission Details

510(k) Number K090163 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2009
Decision Date April 01, 2009
Days to Decision 69 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

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