FDA.reportPublic FDA data

510(k) K101271

Device
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
Applicant
MEDTRONIC INC.
510(k) number
K101271
Product code
JOX  
Decision
Substantially Equivalent (SESE)
Decision date
2010-10-13
Date received
2010-05-06
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
JEFFREY L KOLL
Address
8200 Coral Sea St. N.E Mounds View MN US 55112 55112

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
K051040HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic Perfusion Systems2005-05-24
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