Cleared Traditional

FOCUS J81F, J83F, J41F, J43F PACING LEADS

K896742 · Ela Medical, Inc. · Cardiovascular
Jul 1990
Decision
229d
Days
Class 3
Risk

About This 510(k) Submission

K896742 is an FDA 510(k) clearance for the FOCUS J81F, J83F, J41F, J43F PACING LEADS, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on July 17, 1990, 229 days after receiving the submission on November 30, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K896742 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1989
Decision Date July 17, 1990
Days to Decision 229 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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