Cleared Traditional

IS4/DF4 Port Plug

K143463 · Oscor, Inc. · Cardiovascular
Mar 2015
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K143463 is an FDA 510(k) clearance for the IS4/DF4 Port Plug, a Pacemaker Lead Adaptor (Class II — Special Controls, product code DTD), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on March 19, 2015, 105 days after receiving the submission on December 4, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.

Submission Details

510(k) Number K143463 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2014
Decision Date March 19, 2015
Days to Decision 105 days
Submission Type Traditional
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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