Cleared Traditional

POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD

K874531 · Intermedics, Inc. · Cardiovascular
Jan 1988
Decision
65d
Days
Class 3
Risk

About This 510(k) Submission

K874531 is an FDA 510(k) clearance for the POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING 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 January 7, 1988, 65 days after receiving the submission on November 3, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K874531 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1987
Decision Date January 07, 1988
Days to Decision 65 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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