Cleared Traditional

MODEL SC-3008 SEQUENTIAL CIRCULATOR

K043423 · Bio Compression Systems, Inc. · Cardiovascular
Feb 2005
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K043423 is an FDA 510(k) clearance for the MODEL SC-3008 SEQUENTIAL CIRCULATOR, 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 February 1, 2005, 50 days after receiving the submission on December 13, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K043423 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2004
Decision Date February 01, 2005
Days to Decision 50 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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