Cleared Traditional

K831926 - IMPLANTABLE ENDOCARDIAL PACING LEADS (FDA 510(k) Clearance)

Class I Cardiovascular device.

K831926 · Oscor, Inc. · Cardiovascular device
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Mar 1984
Decision
271d
Days
Class 1
Risk

K831926 is an FDA 510(k) clearance for the IMPLANTABLE ENDOCARDIAL PACING LEADS. Classified as Magnet, Test, Pacemaker (product code DTG), Class I - General Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 271 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3690 - 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: Standard predicate-based submission. Standard predicate reliance. 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 Oscor, Inc. devices

Submission Details

510(k) Number K831926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1983
Decision Date March 12, 1984
Days to Decision 271 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 125d · This submission: 271d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTG Magnet, Test, Pacemaker
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.3690
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.