Cleared Traditional

SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING

K123990 · Medtronic Vascular · Cardiovascular
Apr 2013
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K123990 is an FDA 510(k) clearance for the SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on April 26, 2013, 121 days after receiving the submission on December 26, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K123990 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2012
Decision Date April 26, 2013
Days to Decision 121 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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