Cleared Traditional

ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201 (K874366) - FDA 510(k) Clearance

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

K874366 · Cordis Leads, Inc. · Cardiovascular device
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Jun 1988
Decision
237d
Days
Class 3
Risk

K874366 is an FDA 510(k) clearance for the ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Cordis Leads, Inc. (Suffield, US). The FDA issued a Cleared decision on June 16, 1988 after a review of 237 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 Cordis Leads, Inc. devices

Submission Details

510(k) Number K874366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1987
Decision Date June 16, 1988
Days to Decision 237 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 125d · This submission: 237d
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 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K874366.
MODEL 5866-34A PACEMAKER LEAD ADAPTOR
K883203 · Medtronic Vascular · Sep 1988
BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD
K883602 · Intermedics, Inc. · Sep 1988
MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD
K882452 · Medtronic Vascular · Aug 1988
MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875178 · Intermedics, Inc. · May 1988
MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT
K881712 · Medtronic Vascular · May 1988
MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875100 · Intermedics, Inc. · May 1988