Cleared Traditional

Compass Cast and MAP

K161408 · Centurion Medical Products Corporation · Cardiovascular
Nov 2016
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K161408 is an FDA 510(k) clearance for the Compass Cast and MAP, a Transducer, Blood-pressure, Extravascular (Class II — Special Controls, product code DRS), submitted by Centurion Medical Products Corporation (Williamston, US). The FDA issued a Cleared decision on November 22, 2016, 186 days after receiving the submission on May 20, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2850.

Submission Details

510(k) Number K161408 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2016
Decision Date November 22, 2016
Days to Decision 186 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRS — Transducer, Blood-pressure, Extravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2850

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