Cleared Special

PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB

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

About This 510(k) Submission

K024053 is an FDA 510(k) clearance for the PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 31, 2003, 53 days after receiving the submission on December 9, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K024053 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DTB — Permanent Pacemaker Electrode
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3680

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