Cleared Special

MODEL 4951M MYOCARDIAL UNIPOLAR LEAD

K031210 · Metronic, Inc. · Cardiovascular
May 2003
Decision
29d
Days
Class 3
Risk

About This 510(k) Submission

K031210 is an FDA 510(k) clearance for the MODEL 4951M MYOCARDIAL UNIPOLAR LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Metronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 16, 2003, 29 days after receiving the submission on April 17, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K031210 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2003
Decision Date May 16, 2003
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

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