Cleared Traditional

OSCOR MEDICAL CORP PERMANENT PACING LEAD (K912867) - FDA 510(k) Clearance

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

K912867 · Oscor Medical Corp. · Cardiovascular device
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Feb 1992
Decision
221d
Days
Class 3
Risk

K912867 is an FDA 510(k) clearance for the OSCOR MEDICAL CORP PERMANENT PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Oscor Medical Corp. (Palm Harbor, US). The FDA issued a Cleared decision on February 4, 1992 after a review of 221 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 Oscor Medical Corp. devices

Submission Details

510(k) Number K912867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1991
Decision Date February 04, 1992
Days to Decision 221 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 125d · This submission: 221d
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 K912867.
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
K915736 · Medtronic Vascular · Dec 1992
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
K921124 · Medtronic Vascular · May 1992
PERMANENT CARDIAC PACING LEADS AND ADAPTORS
K912464 · Medtronic Vascular · Feb 1992
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS
K913288 · Medtronic Vascular · Oct 1991
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD
K912235 · Intermedics, Inc. · Sep 1991
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
K903948 · Intermedics, Inc. · Apr 1991