Cleared Traditional

ASTRA T2, ASTRA T4, ASTRA T6

K920601 · Cardiac Pacemakers, Inc. · Cardiovascular
Oct 1992
Decision
260d
Days
Class 3
Risk

About This 510(k) Submission

K920601 is an FDA 510(k) clearance for the ASTRA T2, ASTRA T4, ASTRA 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 October 28, 1992, 260 days after receiving the submission on February 11, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K920601 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1992
Decision Date October 28, 1992
Days to Decision 260 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

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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