Cleared Special

Streamline 6495 Bipolar Temporary Myocardial Pacing Lead

K161249 · Medtronic · Cardiovascular
Aug 2016
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K161249 is an FDA 510(k) clearance for the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, a Electrode, Pacemaker, Temporary (Class II — Special Controls, product code LDF), submitted by Medtronic (Santa Ana, US). The FDA issued a Cleared decision on August 19, 2016, 108 days after receiving the submission on May 3, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K161249 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2016
Decision Date August 19, 2016
Days to Decision 108 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LDF — Electrode, Pacemaker, Temporary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3680

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