Cleared Special

HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)

K111339 · Medtronic, Inc. · Hematology
Jun 2011
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K111339 is an FDA 510(k) clearance for the HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS), a Analyzer, Heparin, Automated (Class II — Special Controls, product code JOX), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on June 8, 2011, 27 days after receiving the submission on May 12, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5680.

Submission Details

510(k) Number K111339 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2011
Decision Date June 08, 2011
Days to Decision 27 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOX — Analyzer, Heparin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5680

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