Cleared Traditional

Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead

K190716 · Medtronic · Cardiovascular
Aug 2019
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K190716 is an FDA 510(k) clearance for the Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar 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 8, 2019, 142 days after receiving the submission on March 19, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K190716 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2019
Decision Date August 08, 2019
Days to Decision 142 days
Submission Type Traditional
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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