Cleared Traditional

K790143 - VENTRICULAR LEAD

K790143 is the FDA 510(k) clearance for VENTRICULAR LEAD by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K790143 · Medtronic Vascular · Cardiovascular device
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Sep 1979
Decision
243d
Days
Class 3
Risk

K790143 is an FDA 510(k) clearance for the VENTRICULAR LEAD, MODEL 6959. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on September 19, 1979 after a review of 243 days - an extended review 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 K790143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1979
Decision Date September 19, 1979
Days to Decision 243 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
118d slower than avg
Panel avg: 125d · This submission: 243d
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 K790143.
IMPLANTABLE ENDOCARDIAL TINED ELECTRODE
K792387 · Telectronics, Inc. · Dec 1979
LIFELINE - ENDOCARDIAL PACING LEAD
K792168 · Intermedics, Inc. · Nov 1979
CORDIS PERMANENT PERVENOUS CARDIAC LEADS
K791768 · Cordis Corp. · Nov 1979
IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC
K791732 · Oscor, Inc. · Sep 1979
MEDTRONIC MODEL 6957
K791769 · Medtronic Vascular · Sep 1979
MODEL 484-01 BIPOLAR COAXIAL PACING LEAD
K791377 · Intermedics, Inc. · Sep 1979