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510(k) K051040

Device
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
Applicant
MEDTRONIC PERFUSION SYSTEMS
510(k) number
K051040
Product code
JOX  
Decision
Substantially Equivalent (SESE)
Decision date
2005-05-24
Date received
2005-04-25
Regulation
864.5680
Classification name
Analyzer, Heparin, Automated
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BRUCE BACKLUND
Address
7611 Northland Dr. Minneapolis MN US 55038 55038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JOX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111339HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)Medtronic, Inc.2011-06-08
K102953HEPARIN DOSE RESPONSE CARTRIDGEMedtronic, Inc.2010-11-04
K101271HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XXMedtronic, Inc.2010-10-13
K043080HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic Vascular2004-12-03
K042070HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20Medtronic Vascular2004-10-01
K993519RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TESTCardiovascular Diagnostics, Inc.2000-01-14
K922031HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROLMedtronic Hemotec, Inc.1992-07-21
K911240HEPCON HMS WITH BODY SURFACE AREA CALCULATIONHemotech, Inc.1991-07-17
K894317HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.Hemotec, Inc.1989-09-05
K854377HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLSHemotec, Inc.1985-12-04
K841021HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAMHemotec, Inc.1984-05-25
K830665HEPCOL SYSTEM B-10 & B-10-PHemotec, Inc.1983-06-08
K813011HEPAQUANTStreck Laboratories, Inc.1982-01-26
K800161HEPCON/SYSTEM RC-10Hemotec, Inc.1980-03-19

Legacy Summary#

summary

FDA Review#

Decision Summary