HEPARIN DOSE RESPONSE CARTRIDGE— 510(k) K102953

Name: FDA 510(k) clearance K102953
Creator: U.S. Food and Drug Administration
Published: 2010-11-04

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K102953 for HEPARIN DOSE RESPONSE CARTRIDGE, Substantially Equivalent on 2010-11-04. 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: 2010-10-04
Decision date: 2010-11-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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