Cleared Traditional

K902002 - MODELS 5069/5071 MYOCARDIAL PACING LEADS

K902002 is an FDA 510(k) clearance for MODELS 5069/5071 MYOCARDIAL PACING LEADS, manufactured by Medtronic Vascular. The device is a Class 3 Cardiovascular device with 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

FDA 510(k) Submission Details - K902002

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.

DTB Device Classification - Class 3, Premarket Approval

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 423
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K902002.
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP
K903927 · Biotronik, GmbH & Co. · Oct 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP
K903928 · Biotronik, GmbH & Co. · Oct 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
K903929 · Biotronik, GmbH & Co. · Oct 1990
BIOTRONIK'S PS-ENDOCARDIAL LEADS
K896824 · Biotronik, GmbH & Co. · Aug 1990
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
K900645 · Telectronics Pacing Systems, Inc. · Aug 1990
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742 · Ela Medical, Inc. · Jul 1990