Cleared Traditional

K862970 - TEMPORARY MYOCARDIAL PACING LEAD

K862970 is the FDA 510(k) clearance for TEMPORARY MYOCARDIAL PACING LEAD by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 415-day FDA review.

K862970 · Medtronic Vascular · Cardiovascular device
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Sep 1987
Decision
415d
Days
Class 2
Risk

K862970 is an FDA 510(k) clearance for the TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500. 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 September 25, 1987 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K862970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1986
Decision Date September 25, 1987
Days to Decision 415 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
290d slower than avg
Panel avg: 125d · This submission: 415d
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 K862970.
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · C.R. Bard, Inc. · Sep 1988
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
K875059 · Daig Corp. · Feb 1988
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728 · Deknatel, Inc. · Nov 1987
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
K855139 · Davis & Geck, Inc. · Feb 1986
MEDTRONIC MODEL 6405
K853818 · Medtronic Vascular · Oct 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913 · Cordis Corp. · Sep 1985