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Disetronic Medical Systems

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
29
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K100704ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICEMay 14, 2010
K070189ACCU-CHEK ULTRAFLEX INFUSION SETFebruary 21, 2007
K063146ACCU-CHEK LINKASSISTNovember 27, 2006
K060876ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP June 15, 2006
K042887ACCU-CHEK SPIRITMarch 18, 2005
K043000MODIFICATION TO D-TRONPLUSDecember 1, 2004
K033892ULTRAFLEX INFUSION SETMarch 9, 2004
K023471DISETRONIC H-TRONPLUS INSULIN INFUSION PUMPOctober 29, 2002
K022831MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMPSeptember 11, 2002
K021725DISETRONIC D-TRON INSULIN INFUSION PUMPAugust 2, 2002
K013782DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLENovember 20, 2001
K003977DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SETFebruary 15, 2001
K001629DISETRONIC MULTIFUSE INFUSION PUMP SYSTEMJune 21, 2000
K994186DISETRONIC D-TRON INSULIN INFUSION PUMPDecember 30, 1999
K994197DISENTRONIC PENFINE INJECTION PEN NEEDLEDecember 29, 1999
K993666DISETRONIC PEN P100November 22, 1999
K991376DAHEDI INSULIN INFUSION PUMPJune 15, 1999
K990259DISETRONIC MULTIFUSE INFUSION PUMP SYSTEMFebruary 12, 1999
K982966DISETRONIC PENOctober 19, 1998
K982399DISETRONIC PENFINE INJECTION PEN NEEDLEAugust 6, 1998