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Minntech Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K120306RAPICIDE OPA-28September 27, 2012
K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMApril 5, 2010
K071298HF JUNIOR HEMOFILTERAugust 8, 2007
K050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORJanuary 31, 2006
K033505RENACLEAN SH DIALYZER CLEANING SYSTEMApril 27, 2004
K014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLERFebruary 1, 2002
K991137ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGERJune 8, 2000
K000028RENAFLO II HF 2000 HEMOFILTERApril 4, 2000
K991851RENACLEAR DIALYZER CLEANING SYSTEMAugust 30, 1999
K983126FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERSMarch 8, 1999
K983085HEMOCOR HPH 700 HEMOCONCENTRATORNovember 13, 1998
K980859HEMOCOR HPH MINI HEMOCONCENTRATORMay 12, 1998
K960513PERACT 20 LIQUID STERILANTOctober 1, 1997
K972017BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)September 10, 1997
K964967BIOCOR 200 HIGH PERFORMANCEOXYGENATORMarch 6, 1997
K962707MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SETOctober 9, 1996
K953821BIOCOR 200 HARDSHELL VENOUS RESERVIORMarch 7, 1996
K954349FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERSDecember 15, 1995
K941439RENALIN COLD STERILANTJune 26, 1995
K945136RENAGUARD DIALYSATE FILTERFebruary 28, 1995