Cleared Special

CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020

K041574 · Guidant Corporation · Cardiovascular
Jul 2004
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K041574 is an FDA 510(k) clearance for the CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020, a Pacemaker Lead Adaptor (Class II — Special Controls, product code DTD), submitted by Guidant Corporation (St. Paul, US). The FDA issued a Cleared decision on July 12, 2004, 28 days after receiving the submission on June 14, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.

Submission Details

510(k) Number K041574 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2004
Decision Date July 12, 2004
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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

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