Company ยท US
Minntech Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2012. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 11 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 4 |
| FIP | Subsystem, Water Purification | 3 |
| LIF | Dialyzer Reprocessing System | 3 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 2 |
| FEB | Accessories, Cleaning, For Endoscope | 2 |
| LRJ | Disinfectant, Medical Devices | 2 |
| MED | Sterilant, Medical Devices | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 |
| FJF | Detector, Air Bubble | 1 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 27, 2012 | K120306 | RAPICIDE OPA-28 Minntech Corp. | MED |
| Apr 5, 2010 | K092387 | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM Minntech Corp. | FEB |
| Aug 8, 2007 | K071298 | HF JUNIOR HEMOFILTER Minntech Corp. | KDI |
| Jan 31, 2006 | K050952 | HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR Minntech Corp. | KDI |
| Apr 27, 2004 | K033505 | RENACLEAN SH DIALYZER CLEANING SYSTEM Minntech Corp. | LIF |
| Feb 1, 2002 | K014016 | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER Minntech Corp. | DWC |
| Jun 8, 2000 | K991137 | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER Minntech Corp. | DTR |
| Apr 4, 2000 | K000028 | RENAFLO II HF 2000 HEMOFILTER Minntech Corp. | KDI |
| Aug 30, 1999 | K991851 | RENACLEAR DIALYZER CLEANING SYSTEM Minntech Corp. | LIF |
| Mar 8, 1999 | K983126 | FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS Minntech Corp. | FIP |
| Nov 13, 1998 | K983085 | HEMOCOR HPH 700 HEMOCONCENTRATOR Minntech Corp. | KDI |
| May 12, 1998 | K980859 | HEMOCOR HPH MINI HEMOCONCENTRATOR Minntech Corp. | KDI |
| Oct 1, 1997 | K960513 | PERACT 20 LIQUID STERILANT Minntech Corp. | MED |
| Sep 10, 1997 | K972017 | BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) Minntech Corp. | DTN |
| Mar 6, 1997 | K964967 | BIOCOR 200 HIGH PERFORMANCEOXYGENATOR Minntech Corp. | DTZ |
| Oct 9, 1996 | K962707 | MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET Minntech Corp. | KDI |
| Mar 7, 1996 | K953821 | BIOCOR 200 HARDSHELL VENOUS RESERVIOR Minntech Corp. | DTN |
| Dec 15, 1995 | K954349 | FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS Minntech Corp. | FIP |
| Jun 26, 1995 | K941439 | RENALIN COLD STERILANT Minntech Corp. | LRJ |
| Feb 28, 1995 | K945136 | RENAGUARD DIALYSATE FILTER Minntech Corp. | FIP |
| Jul 29, 1994 | K923727 | PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 Minntech Corp. | KDI |
| Jul 26, 1994 | K934292 | WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR Minntech Corp. | DTZ |
| Feb 18, 1994 | K923312 | HIGH PERMEABILITY DIALYER Minntech Corp. | KDI |
| Feb 18, 1994 | K923139 | HEMOCOR HP HEMOCONCENTRATOR SERIES Minntech Corp. | KDI |
| Feb 7, 1994 | K931935 | ENDPOINT 500 PERACETIC ACID TEST INDICATORS Minntech Corp. | JOJ |
| Sep 27, 1991 | K913483 | MINNILERT(R) PRESSURE MONITOR Minntech Corp. | KOC |
| Apr 9, 1991 | K910236 | RENAFLO HDF 1350 HEMODIAFILTER Minntech Corp. | KDI |
| Feb 5, 1991 | K904992 | MINNILERT AIR DETECTOR Minntech Corp. | FJF |
| Nov 27, 1990 | K904210 | RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 Minntech Corp. | LIF |
| Nov 1, 1989 | K894970 | WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR Minntech Corp. | DTZ |
| Jan 9, 1989 | K882564 | RENALIN COLD STERILANT Minntech Corp. | LRJ |
| Sep 15, 1987 | K872456 | HEMOCOR PLUS HEMOCONCENTRATOR Minntech Corp. | KDI |
| Aug 28, 1987 | K872107 | WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR Minntech Corp. | DTZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2010 | Minntech Corp DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endo Terminated |
FEB | K914145 |