Cleared Traditional

K861493 - OSCOR MEDICAL FIX SCREW PACING LEAD/PEE...

K861493 is the FDA 510(k) clearance for OSCOR MEDICAL FIX SCREW PACING LEAD/PEE... by Oscor Medical Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K861493 · Oscor Medical Corp. · Cardiovascular device
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Aug 1986
Decision
128d
Days
Class 3
Risk

K861493 is an FDA 510(k) clearance for the OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH. 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 August 28, 1986 after a review of 128 days - within the typical 510(k) review window.

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 K861493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1986
Decision Date August 28, 1986
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
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 K861493.
BIOTRONIK PERMANENT PACEMAKER ELECTRODE
K863480 · Biotronik Sales, Inc. · Sep 1986
MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD
K862053 · Intermedics, Inc. · Sep 1986
MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD
K862054 · Intermedics, Inc. · Sep 1986
MODIFIED OSCOR PY PACING LEADS
K862330 · Oscor Medical Corp. · Aug 1986
CORDIS ANCOR ACTIVE FIXATION LEAD
K832422 · Cordis Corp. · Aug 1986
CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR
K851064 · Cordis Corp. · Aug 1986