Not Cleared Traditional

MODEL 430-07 ENDOCARDIAL PACING LEAD

K954610 · Intermedics, Inc. · Cardiovascular
Dec 1996
Decision
439d
Days
Class 3
Risk

About This 510(k) Submission

K954610 is an FDA 510(k) submission for the MODEL 430-07 ENDOCARDIAL PACING LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Not Cleared (DENG) decision on December 16, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K954610 FDA.gov
FDA Decision Not Cleared PT
Date Received October 04, 1995
Decision Date December 16, 1996
Days to Decision 439 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

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

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