Cleared Traditional

SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE

K081986 · Oscor, Inc. · Cardiovascular
Nov 2008
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K081986 is an FDA 510(k) clearance for the SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE, a Trocar (Class II — Special Controls, product code DRC), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on November 14, 2008, 123 days after receiving the submission on July 14, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K081986 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2008
Decision Date November 14, 2008
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRC — Trocar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1390

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