Cleared Traditional

SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE

K130843 · Oscor, Inc. · Cardiovascular
Jan 2014
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K130843 is an FDA 510(k) clearance for the SAFESEPT NEEDLE FREE 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 January 8, 2014, 287 days after receiving the submission on March 27, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K130843 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2013
Decision Date January 08, 2014
Days to Decision 287 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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

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