Cleared Traditional

ENDOCARDIAL CARBON-TIP LEAD (K861481) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K861481 · Pacesetter Systems · Cardiovascular device
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Jun 1986
Decision
45d
Days
Class 3
Risk

K861481 is an FDA 510(k) clearance for the ENDOCARDIAL CARBON-TIP LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on June 6, 1986 after a review of 45 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 Pacesetter Systems devices

Submission Details

510(k) Number K861481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1986
Decision Date June 06, 1986
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
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 486
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K861481.
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · Medtronic Vascular · May 2003
MODEL 430-07 ENDOCARDIAL PACING LEAD
K954610 · Intermedics, Inc. · Dec 1996
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K955122 · Intermedics, Inc. · Nov 1996
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
K962036 · Medtronic Vascular · Aug 1996
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
K962174 · Intermedics, Inc. · Aug 1996
MODEL 2188 CORONARY SINUS LEAD.
K961936 · Medtronic Vascular · Aug 1996