Cleared Traditional

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

K210417 · Bio Compression Systems, Inc. · Cardiovascular
May 2021
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K210417 is an FDA 510(k) clearance for the Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Bio Compression Systems, Inc. (Moonachie, US). The FDA issued a Cleared decision on May 14, 2021, 92 days after receiving the submission on February 11, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K210417 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2021
Decision Date May 14, 2021
Days to Decision 92 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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