Cleared Traditional

MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS

K890412 · Intermedics, Inc. · Cardiovascular
Mar 1989
Decision
63d
Days
Class 3
Risk

About This 510(k) Submission

K890412 is an FDA 510(k) clearance for the MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on March 28, 1989, 63 days after receiving the submission on January 24, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K890412 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1989
Decision Date March 28, 1989
Days to Decision 63 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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