Cleared Traditional

K913205 - OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH

K913205 is the FDA 510(k) clearance for OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH by Oscor Medical Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K913205 · Oscor Medical Corp. · Cardiovascular device
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Sep 1991
Decision
77d
Days
Class 3
Risk

K913205 is an FDA 510(k) clearance for the OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF. 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 K913205 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
Combination Product No
PCCP Authorized No
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 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K913205.
IMPLANT PACING LEAD, TINED #3262, MODIFICATION
K913202 · Oscor Medical Corp. · Sep 1991
IMPLANT PACING LEAD TINED #3390, MODIFICATION
K913203 · Oscor Medical Corp. · Sep 1991
MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION
K913204 · Oscor Medical Corp. · Sep 1991
IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION
K913393 · Oscor Medical Corp. · Sep 1991
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD
K912235 · Intermedics, Inc. · Sep 1991
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
K910924 · Pacesetter Systems · Aug 1991