Cleared Special

Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead

K171253 · Medtronic · Cardiovascular
May 2017
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K171253 is an FDA 510(k) clearance for the Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 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 May 25, 2017, 27 days after receiving the submission on April 28, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K171253 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2017
Decision Date May 25, 2017
Days to Decision 27 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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