Cleared Traditional

Liberator Beacon Tip Locking Stylet

K170298 · Cook Incorporated · Cardiovascular
Oct 2017
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K170298 is an FDA 510(k) clearance for the Liberator Beacon Tip Locking Stylet, a Stylet, Catheter (Class II — Special Controls, product code DRB), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 18, 2017, 260 days after receiving the submission on January 31, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1380.

Submission Details

510(k) Number K170298 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2017
Decision Date October 18, 2017
Days to Decision 260 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRB — Stylet, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1380

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