Cleared Traditional

MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004

K882429 · Tpl-Cordis, Inc. · Cardiovascular
Jul 1988
Decision
38d
Days
Class 3
Risk

About This 510(k) Submission

K882429 is an FDA 510(k) clearance for the MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004, a Programmer, Pacemaker (Class III — Premarket Approval, product code KRG), submitted by Tpl-Cordis, Inc. (Englewood, US). The FDA issued a Cleared decision on July 22, 1988, 38 days after receiving the submission on June 14, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3700.

Submission Details

510(k) Number K882429 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1988
Decision Date July 22, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code KRG — Programmer, Pacemaker
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3700

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