Cleared Traditional

K842031 - TRANSVENOUS TINED VENTRICULAR/ATRIAL

K842031 is the FDA 510(k) clearance for TRANSVENOUS TINED VENTRICULAR/ATRIAL by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K842031 · Medtronic Vascular · Cardiovascular device
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Jan 1985
Decision
245d
Days
Class 3
Risk

K842031 is an FDA 510(k) clearance for the TRANSVENOUS TINED VENTRICULAR/ATRIAL. 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 18, 1985 after a review of 245 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 K842031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1984
Decision Date January 18, 1985
Days to Decision 245 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
120d slower than avg
Panel avg: 125d · This submission: 245d
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 K842031.
MODEL 479-01 PACING LEAD
K844271 · Intermedics, Inc. · Mar 1985
MODEL 473-03 PACING LEAD
K844272 · Intermedics, Inc. · Mar 1985
CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS
K844970 · Cordis Corp. · Mar 1985
MODELS 4012/4512 TRANSVENOUS TINED-
K842032 · Medtronic Vascular · Jan 1985
MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN
K844959 · Medtronic Vascular · Jan 1985
MEDTRONIC 6957J
K843707 · Medtronic Vascular · Jan 1985