Cleared Traditional

K874792 - MODEL 5013 TRANSVENOUS VENTRICULAR PACI...

K874792 is the FDA 510(k) clearance for MODEL 5013 TRANSVENOUS VENTRICULAR PACI... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K874792 · Medtronic Vascular · Cardiovascular device
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Jan 1988
Decision
60d
Days
Class 3
Risk

K874792 is an FDA 510(k) clearance for the MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD. 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 January 19, 1988 after a review of 60 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. 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 K874792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1987
Decision Date January 19, 1988
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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 K874792.
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
K873962 · Medtronic Vascular · Feb 1988
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T
K874205 · Pacesetter Systems · Feb 1988
ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD
K874183 · Daig Corp. · Jan 1988
POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD
K874531 · Intermedics, Inc. · Jan 1988
MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER
K874930 · Intermedics, Inc. · Jan 1988
MEDTRONIC PERMANENT LEAD INTRODUCER
K874167 · Medtronic Vascular · Dec 1987