Cleared Traditional

LEAD STYLET

K905674 · Cardiac Pacemakers, Inc. · Cardiovascular
Jan 1991
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K905674 is an FDA 510(k) clearance for the LEAD STYLET, a Stylet, Catheter (Class II — Special Controls, product code DRB), submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 30, 1991, 43 days after receiving the submission on December 18, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1380.

Submission Details

510(k) Number K905674 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1990
Decision Date January 30, 1991
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

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