Cleared Special

HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

K043080 · Medtronic Vascular · Hematology
Dec 2004
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K043080 is an FDA 510(k) clearance for the HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR, a Analyzer, Heparin, Automated (Class II — Special Controls, product code JOX), submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 3, 2004, 25 days after receiving the submission on November 8, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5680.

Submission Details

510(k) Number K043080 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2004
Decision Date December 03, 2004
Days to Decision 25 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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