Cleared Traditional

CARDIFIX ENDOCARDIAL PACING LEAD

K922042 · Intermedics, Inc. · Cardiovascular
Apr 1993
Decision
363d
Days
Class 3
Risk

About This 510(k) Submission

K922042 is an FDA 510(k) clearance for the CARDIFIX ENDOCARDIAL PACING LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on April 29, 1993, 363 days after receiving the submission on May 1, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K922042 FDA.gov
FDA Decision Cleared SESP
Date Received May 01, 1992
Decision Date April 29, 1993
Days to Decision 363 days
Submission Type Traditional
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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