Cleared Traditional

Hydroven 12, Hydroven 12 Garments

K152228 · Huntleigh Healthcare , Ltd. · Cardiovascular
Apr 2016
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K152228 is an FDA 510(k) clearance for the Hydroven 12, Hydroven 12 Garments, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Huntleigh Healthcare , Ltd. (Cardiff, GB). The FDA issued a Cleared decision on April 4, 2016, 241 days after receiving the submission on August 7, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K152228 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2015
Decision Date April 04, 2016
Days to Decision 241 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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