Cleared Traditional

MODEL 5866-9M & MODEL 6981M

K911827 · Metronic, Inc. · Cardiovascular
Jul 1991
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K911827 is an FDA 510(k) clearance for the MODEL 5866-9M & MODEL 6981M, a Pacemaker Lead Adaptor (Class II — Special Controls, product code DTD), submitted by Metronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 23, 1991, 90 days after receiving the submission on April 24, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.

Submission Details

510(k) Number K911827 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1991
Decision Date July 23, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTD — Pacemaker Lead Adaptor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3620

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