Cleared Special

HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX

K101271 · Medtronic, Inc. · Hematology
Oct 2010
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K101271 is an FDA 510(k) clearance for the HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX, 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 October 13, 2010, 160 days after receiving the submission on May 6, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5680.

Submission Details

510(k) Number K101271 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2010
Decision Date October 13, 2010
Days to Decision 160 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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