Cleared Traditional

PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS

K010787 · Oscor, Inc. · Cardiovascular
May 2001
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K010787 is an FDA 510(k) clearance for the PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS, 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 May 22, 2001, 68 days after receiving the submission on March 15, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.

Submission Details

510(k) Number K010787 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2001
Decision Date May 22, 2001
Days to Decision 68 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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