Cleared Traditional

ASTRA 2, ASTRA 3, 4 & 6

K842394 · Cardiac Pacemakers, Inc. · Cardiovascular
Oct 1984
Decision
120d
Days
Class 3
Risk

About This 510(k) Submission

K842394 is an FDA 510(k) clearance for the ASTRA 2, ASTRA 3, 4 & 6, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 17, 1984, 120 days after receiving the submission on June 19, 1984. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K842394 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1984
Decision Date October 17, 1984
Days to Decision 120 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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