Cleared Traditional

MODEL 484-01 BIPOLAR COAXIAL PACING LEAD (K791377) - FDA 510(k) Clearance

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

K791377 · Intermedics, Inc. · Cardiovascular device
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Sep 1979
Decision
50d
Days
Class 3
Risk

K791377 is an FDA 510(k) clearance for the MODEL 484-01 BIPOLAR COAXIAL PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1979 after a review of 50 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 Intermedics, Inc. devices

Submission Details

510(k) Number K791377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1979
Decision Date September 12, 1979
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
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 221
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K791377.
CORDIS PERMANENT PERVENOUS CARDIAC LEADS
K791768 · Cordis Corp. · Nov 1979
VENTRICULAR LEAD, MODEL 6959
K790143 · Medtronic Vascular · Sep 1979
MEDTRONIC MODEL 6957
K791769 · Medtronic Vascular · Sep 1979
MODEL 482-01 BIPOLAR COAXIAL PACING LEAD
K791378 · Intermedics, Inc. · Sep 1979
MEDTRONIC MODELS 69914/699OU
K791667 · Medtronic Vascular · Sep 1979
MEDTRONIC MODEL 6957
K790429 · Medtronic Vascular · Jul 1979