CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL


Device Classification Name

plasma, coagulation control

510(k) Number K103314
Device Name CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
Applicant
MEDTRONIC INC.
8200 coral sea street ne
mounds view, 
MN 
55112

Applicant Contact jeffrey l koll
Correspondent
MEDTRONIC INC.
8200 coral sea street ne
mounds view, 
MN 
55112

Correspodent Contact jeffrey l koll
Regulation Number 864.5425
Classification Product Code
GGN  
Date Received 11/10/2010
Decision Date 12/03/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No