Cleared Traditional

K902342 - UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD

K902342 is the FDA 510(k) clearance for UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K902342 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
144d
Days
Class 2
Risk

K902342 is an FDA 510(k) clearance for the UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 16, 1990 after a review of 144 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K902342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1990
Decision Date October 16, 1990
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 77
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K902342.
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491
K922268 · Medtronic Vascular · Nov 1992
MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
K923407 · Medtronic Vascular · Oct 1992
PACEL(TM) FLOW DIRECTED PACING CATHETER
K914185 · Daig Corp. · Jan 1992
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789 · Medtronic Vascular · Dec 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
K890794 · Daig Corp. · Jun 1989
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · C.R. Bard, Inc. · Sep 1988