Cleared Traditional

K874167 - MEDTRONIC PERMANENT LEAD INTRODUCER

K874167 is the FDA 510(k) clearance for MEDTRONIC PERMANENT LEAD INTRODUCER by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K874167 · Medtronic Vascular · Cardiovascular device
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Dec 1987
Decision
55d
Days
Class 3
Risk

K874167 is an FDA 510(k) clearance for the MEDTRONIC PERMANENT LEAD INTRODUCER. 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 December 7, 1987 after a review of 55 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 K874167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date December 07, 1987
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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 K874167.
MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD
K874792 · Medtronic Vascular · 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
MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE
K873921 · Intermedics, Inc. · Dec 1987
MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD
K870885 · Medtronic Vascular · Nov 1987
MODIFIED MODELS 1025M & 1026T PACING LEAD
K873931 · Pacesetter Systems · Oct 1987