Cleared Traditional

ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33

K894718 · Intermedics, Inc. · Cardiovascular
Sep 1989
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K894718 is an FDA 510(k) clearance for the ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33, a Pacemaker Lead Adaptor (Class II — Special Controls, product code DTD), submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on September 5, 1989, 42 days after receiving the submission on July 25, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.

Submission Details

510(k) Number K894718 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1989
Decision Date September 05, 1989
Days to Decision 42 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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