Cleared Traditional

IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION (K913393) - FDA 510(k) Clearance

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

K913393 · Oscor Medical Corp. · Cardiovascular device
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Sep 1991
Decision
77d
Days
Class 3
Risk

K913393 is an FDA 510(k) clearance for the IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION. 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 September 23, 1991 after a review of 77 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 Oscor Medical Corp. devices

Submission Details

510(k) Number K913393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date September 23, 1991
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 K913393.
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
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD
K902672 · Intermedics, Inc. · Mar 1991