Cleared Traditional

Chariot Guiding Sheath

K150186 · Boston Scientific Corp · Cardiovascular
Jun 2015
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K150186 is an FDA 510(k) clearance for the Chariot Guiding Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on June 5, 2015, 129 days after receiving the submission on January 27, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K150186 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2015
Decision Date June 05, 2015
Days to Decision 129 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340

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