Cleared Traditional

EnSite Velocity Cardiac Mapping System v5.2

K172396 · St Jude Medical · Cardiovascular
Apr 2018
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K172396 is an FDA 510(k) clearance for the EnSite Velocity Cardiac Mapping System v5.2, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by St Jude Medical (St. Paul, US). The FDA issued a Cleared decision on April 23, 2018, 258 days after receiving the submission on August 8, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K172396 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2017
Decision Date April 23, 2018
Days to Decision 258 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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