Cleared Traditional

PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860

K872731 · Ela Medical, Inc. · Cardiovascular
Sep 1987
Decision
69d
Days
Class 3
Risk

About This 510(k) Submission

K872731 is an FDA 510(k) clearance for the PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860, 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 September 15, 1987, 69 days after receiving the submission on July 8, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K872731 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1987
Decision Date September 15, 1987
Days to Decision 69 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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