Cleared Traditional

MULTILITH 3 MODELS 1350, 3350, 1370, 3370

K863898 · Ela Medical, Inc. · Cardiovascular
Feb 1987
Decision
126d
Days
Class 3
Risk

About This 510(k) Submission

K863898 is an FDA 510(k) clearance for the MULTILITH 3 MODELS 1350, 3350, 1370, 3370, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on February 10, 1987, 126 days after receiving the submission on October 7, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K863898 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1986
Decision Date February 10, 1987
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DXY — Implantable Pacemaker Pulse-generator
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3610

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