Cleared Special

PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV

K031164 · Oscor, Inc. · Cardiovascular
Jun 2003
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K031164 is an FDA 510(k) clearance for the PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV, 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 June 19, 2003, 66 days after receiving the submission on April 14, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.

Submission Details

510(k) Number K031164 FDA.gov
FDA Decision Cleared ST
Date Received April 14, 2003
Decision Date June 19, 2003
Days to Decision 66 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary —

Device Classification

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

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