Cleared Traditional

IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE

K131306 · Bio Compression Systems, Inc. · Cardiovascular
Jul 2013
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K131306 is an FDA 510(k) clearance for the IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Bio Compression Systems, Inc. (Oms River, US). The FDA issued a Cleared decision on July 22, 2013, 76 days after receiving the submission on May 7, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K131306 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2013
Decision Date July 22, 2013
Days to Decision 76 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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