Cleared Special

K024053 - PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (FDA 510(k) Clearance)

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

K024053 · Oscor, Inc. · Cardiovascular device
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Jan 2003
Decision
53d
Days
Class 3
Risk

K024053 is an FDA 510(k) clearance for the PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 31, 2003 after a review of 53 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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, Inc. devices

Submission Details

510(k) Number K024053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2002
Decision Date January 31, 2003
Days to Decision 53 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

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.