Cleared Traditional

MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD

K875100 · Intermedics, Inc. · Cardiovascular
May 1988
Decision
166d
Days
Class 3
Risk

About This 510(k) Submission

K875100 is an FDA 510(k) clearance for the MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on May 24, 1988, 166 days after receiving the submission on December 10, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K875100 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1987
Decision Date May 24, 1988
Days to Decision 166 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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