Cleared Traditional

MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER

K874930 · Intermedics, Inc. · Cardiovascular
Jan 1988
Decision
35d
Days
Class 3
Risk

About This 510(k) Submission

K874930 is an FDA 510(k) clearance for the MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on January 6, 1988, 35 days after receiving the submission on December 2, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K874930 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1987
Decision Date January 06, 1988
Days to Decision 35 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTB — Permanent Pacemaker Electrode
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3680

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