HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)— 510(k) K111339

Name: FDA 510(k) clearance K111339
Creator: U.S. Food and Drug Administration
Published: 2011-06-08

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K111339 for HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS), Substantially Equivalent on 2011-06-08. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code JOX
Device class: Class 2
Regulation: 21 CFR 864.5680
Advisory panel: Hematology
Date received: 2011-05-12
Decision date: 2011-06-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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K042070 — HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-202004-10-01

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