Cleared Traditional

VICOR PACER, MODEL 410A

K880432 · Tpl-Cordis, Inc. · Cardiovascular
Feb 1988
Decision
25d
Days
Class 3
Risk

About This 510(k) Submission

K880432 is an FDA 510(k) clearance for the VICOR PACER, MODEL 410A, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Tpl-Cordis, Inc. (Suffield, US). The FDA issued a Cleared decision on February 22, 1988, 25 days after receiving the submission on January 28, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K880432 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 1988
Decision Date February 22, 1988
Days to Decision 25 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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