Cleared Traditional

SENTRA

K843060 · Cardiac Pacemakers, Inc. · Cardiovascular
Sep 1984
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K843060 is an FDA 510(k) clearance for the SENTRA, a Pacemaker Lead Adaptor (Class II — Special Controls, product code DTD), submitted by Cardiac Pacemakers, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1984, 48 days after receiving the submission on August 3, 1984. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.

Submission Details

510(k) Number K843060 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1984
Decision Date September 20, 1984
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTD — Pacemaker Lead Adaptor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3620

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