Cleared Traditional

BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)

K962174 · Intermedics, Inc. · Cardiovascular
Aug 1996
Decision
77d
Days
Class 3
Risk

About This 510(k) Submission

K962174 is an FDA 510(k) clearance for the BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07), a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on August 21, 1996, 77 days after receiving the submission on June 5, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K962174 FDA.gov
FDA Decision Cleared ST
Date Received June 05, 1996
Decision Date August 21, 1996
Days to Decision 77 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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