Medical Device Manufacturer · US , Minneapolis , MN

Minntech Corp. - FDA 510(k) Cleared Devices

33 submissions · 33 cleared · Since 1987
33
Total
33
Cleared
0
Denied

FDA 510(k) Regulatory Record - Minntech Corp. Gastroenterology & Urology

19 devices
1-19 of 19
Cleared Aug 08, 2007
HF JUNIOR HEMOFILTER
K071298 · KDI
Gastroenterology & Urology · 91d
Cleared Jan 31, 2006
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
K050952 · KDI
Gastroenterology & Urology · 291d
Cleared Apr 27, 2004
RENACLEAN SH DIALYZER CLEANING SYSTEM
K033505 · LIF
Gastroenterology & Urology · 174d
Cleared Apr 04, 2000
RENAFLO II HF 2000 HEMOFILTER
K000028 · KDI
Gastroenterology & Urology · 90d
Cleared Aug 30, 1999
RENACLEAR DIALYZER CLEANING SYSTEM
K991851 · LIF
Gastroenterology & Urology · 90d
Cleared Mar 08, 1999
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
K983126 · FIP
Gastroenterology & Urology · 181d
Cleared Nov 13, 1998
HEMOCOR HPH 700 HEMOCONCENTRATOR
K983085 · KDI
Gastroenterology & Urology · 71d
Cleared May 12, 1998
HEMOCOR HPH MINI HEMOCONCENTRATOR
K980859 · KDI
Gastroenterology & Urology · 68d
Cleared Oct 09, 1996
MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET
K962707 · KDI
Gastroenterology & Urology · 89d
Cleared Dec 15, 1995
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
K954349 · FIP
Gastroenterology & Urology · 88d
Cleared Feb 28, 1995
RENAGUARD DIALYSATE FILTER
K945136 · FIP
Gastroenterology & Urology · 131d
Cleared Jul 29, 1994
PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000
K923727 · KDI
Gastroenterology & Urology · 732d
Cleared Feb 18, 1994
HEMOCOR HP HEMOCONCENTRATOR SERIES
K923139 · KDI
Gastroenterology & Urology · 599d
Cleared Feb 18, 1994
HIGH PERMEABILITY DIALYER
K923312 · KDI
Gastroenterology & Urology · 591d
Cleared Sep 27, 1991
MINNILERT(R) PRESSURE MONITOR
K913483 · KOC
Gastroenterology & Urology · 52d
Cleared Apr 09, 1991
RENAFLO HDF 1350 HEMODIAFILTER
K910236 · KDI
Gastroenterology & Urology · 81d
Cleared Feb 05, 1991
MINNILERT AIR DETECTOR
K904992 · FJF
Gastroenterology & Urology · 90d
Cleared Nov 27, 1990
RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
K904210 · LIF
Gastroenterology & Urology · 76d
Cleared Sep 15, 1987
HEMOCOR PLUS HEMOCONCENTRATOR
K872456 · KDI
Gastroenterology & Urology · 84d
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