Cleared Special

K140972 - UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING

K140972 is an FDA 510(k) clearance for UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Special 510(k) pathway after a 51-day FDA review.

K140972 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
51d
Days
Class 2
Risk

K140972 is an FDA 510(k) clearance for the UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LE.... Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Medtronic, Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 6, 2014 after a review of 51 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140972

510(k) Number K140972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2014
Decision Date June 06, 2014
Days to Decision 51 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

LDF Device Classification - Class 2, Special Controls

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 105
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K140972.
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
K161249 · Medtronic · Aug 2016
Pacel Bipolar Pacing Catheters
K152784 · St Jude Medical · Oct 2015
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
K152633 · Edwards Lifesciences, LLC · Oct 2015
TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)
K072770 · Oscor, Inc. · Jan 2008
MODEL 6416 TEMPORARY PACING LEAD SYSTEM
K042190 · Medtronic Vascular · Sep 2004
DETECT SURGICAL PACING AND MAPPING TOOL
K040812 · Medtronic Vascular · Sep 2004
K140972 · UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING
Download PDF FDA Summary Medtronic, Inc.