Not Cleared Traditional

K964107 - OSCOR PERMANENT RETRACTABLE SCREW-IN PA...

K964107 is the FDA 510(k) submission for OSCOR PERMANENT RETRACTABLE SCREW-IN PA... by Oscor Medical Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K964107 · Oscor Medical Corp. · Cardiovascular device
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Apr 1997
Decision
168d
Days
Class 3
Risk

K964107 is an FDA 510(k) submission (not cleared) for the OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Oscor Medical Corp. (Palm Harbor, US). The FDA issued a Not Cleared (DENG) decision on April 1, 1997 after a review of 168 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

View all Oscor Medical Corp. devices

Submission Details

510(k) Number K964107 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received October 15, 1996
Decision Date April 01, 1997
Days to Decision 168 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
43d slower than avg
Panel avg: 125d · This submission: 168d
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 K964107.
ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
K965106 · Biotronik, Inc. · Jan 1998
STELA MODEL UJ45 PACING LEADS
K972574 · Ela Medical, Inc. · Jan 1998
STELA MODEL BJ44 AND BJ45 PACING LEADS
K963738 · Ela Medical, Inc. · May 1997
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
K964604 · Biotronik, Inc. · Mar 1997
MODEL 430-07 ENDOCARDIAL PACING LEAD
K954610 · Intermedics, Inc. · Dec 1996
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K955122 · Intermedics, Inc. · Nov 1996