Cleared Traditional

ASTRA T2, T4 AND T6

K865013 · Cardiac Pacemakers, Inc. · Cardiovascular
Feb 1987
Decision
58d
Days
Class 3
Risk

About This 510(k) Submission

K865013 is an FDA 510(k) clearance for the ASTRA T2, T4 AND T6, 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 February 19, 1987, 58 days after receiving the submission on December 23, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K865013 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1986
Decision Date February 19, 1987
Days to Decision 58 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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