Cleared Traditional

K902002 - MODELS 5069/5071 MYOCARDIAL PACING LEADS

K902002 is the FDA 510(k) clearance for MODELS 5069/5071 MYOCARDIAL PACING LEADS by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K902002 · Medtronic Vascular · Cardiovascular device
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Sep 1990
Decision
147d
Days
Class 3
Risk

K902002 is an FDA 510(k) clearance for the MODELS 5069/5071 MYOCARDIAL PACING LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on September 26, 1990 after a review of 147 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: High-complexity regulatory submission. High regulatory complexity profile. 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 K902002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1990
Decision Date September 26, 1990
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 364
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K902002.
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS
K910528 · Possis Medical, Inc. · Aug 1991
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
K903948 · Intermedics, Inc. · Apr 1991
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD
K902672 · Intermedics, Inc. · Mar 1991
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742 · Ela Medical, Inc. · Jul 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147 · Pacesetter Systems · Jul 1990
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984 · Medtronic Vascular · May 1990