Cleared Special

Sequential Circulator SC-2004FC-OC

K171793 · Bio Compression Systems, Inc. · Cardiovascular
Aug 2017
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K171793 is an FDA 510(k) clearance for the Sequential Circulator SC-2004FC-OC, 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 August 17, 2017, 62 days after receiving the submission on June 16, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K171793 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2017
Decision Date August 17, 2017
Days to Decision 62 days
Submission Type Special
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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