Cleared Special

K161249 - Streamline 6495 Bipolar Temporary Myocardial Pacing Lead (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161249 · Medtronic · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
108d
Days
Class 2
Risk

K161249 is an FDA 510(k) clearance for the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Medtronic (Santa Ana, US). The FDA issued a Cleared decision on August 19, 2016 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic devices

Submission Details

510(k) Number K161249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LDF Electrode, Pacemaker, Temporary

All 127
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K161249.
Bioptimal Bipolar Pacing Catheter
K242863 · Bioptimal International Pte. , Ltd. · Jun 2025
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
K251186 · C.R. Bard, Inc. · May 2025
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P)
K241334 · C.R. Bard, Inc. · Jan 2025
Rotatable Connector (5944RL)
K241199 · Shenzhen Launch Electrical Co., Ltd. · Jan 2025
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
K242705 · Medtronic, Inc. · Jan 2025
TME Temporary Myocardial Electrode
K232261 · Osypka AG · Apr 2024