Cleared Special

6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP

K132008 · Medtronic, Inc. · Cardiovascular
Jul 2013
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K132008 is an FDA 510(k) clearance for the 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP, a Pacemaker Lead Adaptor (Class II — Special Controls, product code DTD), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on July 30, 2013, 29 days after receiving the submission on July 1, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.

Submission Details

510(k) Number K132008 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2013
Decision Date July 30, 2013
Days to Decision 29 days
Submission Type Special
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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