Cleared Traditional

BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD

K883602 · Intermedics, Inc. · Cardiovascular
Sep 1988
Decision
14d
Days
Class 3
Risk

About This 510(k) Submission

K883602 is an FDA 510(k) clearance for the BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on September 6, 1988, 14 days after receiving the submission on August 23, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K883602 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 1988
Decision Date September 06, 1988
Days to Decision 14 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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