Cleared Special

PERMANENT PACING LEAD, MODEL PY2

K041809 · Oscor, Inc. · Cardiovascular
Aug 2004
Decision
31d
Days
Class 3
Risk

About This 510(k) Submission

K041809 is an FDA 510(k) clearance for the PERMANENT PACING LEAD, MODEL PY2, 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 August 6, 2004, 31 days after receiving the submission on July 6, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K041809 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2004
Decision Date August 06, 2004
Days to Decision 31 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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