Cleared Traditional

K160318 - PlasmaFlow
(FDA 510(k) Clearance)

K160318 · Manamed, Inc. · Cardiovascular
Apr 2016
Decision
56d
Days
Class 2
Risk

K160318 is an FDA 510(k) clearance for the PlasmaFlow, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Manamed, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on April 1, 2016, 56 days after receiving the submission on February 5, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K160318 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2016
Decision Date April 01, 2016
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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