Company ยท US
3M Health Care, Sarns
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1996. Name variants (Inc, Corp, punctuation) are merged.
76510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 21 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 9 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 6 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 5 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 4 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 3 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 3 |
| DTP | Defoamer, Cardiopulmonary Bypass | 2 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 2 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 2 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 2 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 2 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 |
| DSJ | Alarm, Blood-Pressure | 1 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 1 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 1 |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | 1 |
| FIR | Pump, Blood, Extra-Luminal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 4, 1996 | K960916 | SAMS 8000 CARDIOPLEGIA MONITOR 3M Health Care, Sarns | DSJ |
| Apr 19, 1996 | K953901 | SARNS 800 ROLLER PUMP 3M Health Care, Sarns | DWB |
| Nov 17, 1995 | K950739 | 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM 3M Health Care, Sarns | DWA |
| Aug 24, 1994 | K941653 | SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION 3M Health Care, Sarns | DTZ |
| Jul 26, 1994 | K941654 | SARNS FILTERED VENOUS RESERVIOR MODIFICATION 3M Health Care, Sarns | DTP |
| May 24, 1994 | K940651 | SARNS ULTRASONIC AIR SENSOR 3M Health Care, Sarns | KRL |
| Feb 24, 1994 | K935391 | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK 3M Health Care, Sarns | GFA |
| Feb 22, 1994 | K934127 | SARNS LOW JETTING AORTIC ARCH CANNULA 3M Health Care, Sarns | DWF |
| Feb 4, 1994 | K935977 | SARNS AIR DETECTION SYSTEM 3M Health Care, Sarns | KRL |
| Sep 9, 1993 | K915547 | SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT 3M Health Care, Sarns | KFM |
| Jun 7, 1993 | K925076 | SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R. 3M Health Care, Sarns | DTZ |
| Jun 7, 1993 | K925075 | SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR 3M Health Care, Sarns | DTZ |
| May 21, 1993 | K925442 | SARNS RETROGRADE CANNULA 3M Health Care, Sarns | DWF |
| May 11, 1993 | K920902 | MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA 3M Health Care, Sarns | DWF |
| Mar 12, 1993 | K922471 | SARNS RETROGRADE CANNULA - AUTO INFLATE 3M Health Care, Sarns | DWF |
| Sep 18, 1992 | K923311 | CONDUCER HEAT EXCHANGER 3M Health Care, Sarns | DTR |
| Jul 8, 1992 | K915183 | SARNS 8000 MODULAR PERFUSION SYSTEM 3M Health Care, Sarns | DTQ |
| Mar 4, 1992 | K915193 | SARNS RETROGRADE CANNULA 3M Health Care, Sarns | DWF |
| Nov 7, 1991 | K913176 | DELPHIN II CENTRIFUGAL SYSTEM 3M Health Care, Sarns | KFM |
| Oct 23, 1991 | K912079 | SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY 3M Health Care, Sarns | DTZ |
| Aug 20, 1991 | K912078 | SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION 3M Health Care, Sarns | DTZ |
| May 29, 1991 | K911227 | NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS 3M Health Care, Sarns | DTZ |
| Feb 25, 1991 | K905686 | SARNS TEMPERATURE PROBE AND CONNECTOR 3M Health Care, Sarns | DWE |
| Feb 5, 1991 | K905224 | CARDIOPULMONARY BYPASS VASCULAR CATHETER 3M Health Care, Sarns | DWF |
| Feb 1, 1991 | K905638 | SARNS INVENT CATHETERS 3M Health Care, Sarns | DWF |
| Oct 19, 1990 | K903436 | SARNS MEMBRANE OXGENATOR PART NUMBER 9443 3M Health Care, Sarns | DTZ |
| Jan 24, 1989 | K884659 | SARNS 9000 WITH CENTRIFUGAL PUMP OPTION 3M Health Care, Sarns | KFM |
| Dec 5, 1988 | K883071 | SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM 3M Health Care, Sarns | DTR |
| Nov 3, 1988 | K883603 | SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) 3M Health Care, Sarns | DWC |
| Oct 13, 1988 | K882758 | CENTRIFUGAL PUMP SYSTEM LX/DX VERSION 3M Health Care, Sarns | KFM |
| Sep 28, 1988 | K883345 | SARNS INFANT VENOUS RESERVOIR MODEL #16387 3M Health Care, Sarns | DTN |
| Feb 18, 1988 | K875048 | SARNS VENOATRIAL CATHETER 3M Health Care, Sarns | DWF |
| Feb 2, 1988 | K874896 | SARNS VISIFLOW AORTIC ARCH CANNULA 3M Health Care, Sarns | DWF |
| Nov 6, 1987 | K873813 | SARNS WARMER, PART #164975 AND #164980 3M Health Care, Sarns | DWC |
| Nov 6, 1987 | K873212 | SARNS CARDIOPLEGIA/VENT CATHETERS 3M Health Care, Sarns | DWF |
| May 21, 1987 | K871131 | SARNS 9000 HEART-LUNG CONSOLE 3M Health Care, Sarns | DTQ |
| May 6, 1987 | K870829 | SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR 3M Health Care, Sarns | DTN |
| Dec 11, 1986 | K863902 | MODIFIED SARNS MEMBRANE OXYGENATOR 3M Health Care, Sarns | DTX |
| Nov 18, 1986 | K863593 | SARNS SAFETY LOOP 3M Health Care, Sarns | DWD |
| Nov 18, 1986 | K863515 | MODIFIED SARNS OXYGENATOR SYSTEM 3M Health Care, Sarns | DTZ |
| Aug 19, 1986 | K862357 | MODIFIED CARDIOTOMY RESERVOIR 5M1470 3M Health Care, Sarns | DTN |
| Jun 23, 1986 | K861388 | SARNS PORTABLE POWER MODULE 3M Health Care, Sarns | DTQ |
| May 28, 1986 | K860702 | SARNS FILTERED CARDIOTOMY RESERVOIR 3M Health Care, Sarns | DTP |
| Apr 29, 1986 | K860539 | SARNS OXYGENATOR SYSTEM 3M Health Care, Sarns | DTZ |
| Nov 14, 1985 | K853516 | SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM 3M Health Care, Sarns | DTR |
| Oct 17, 1985 | K853128 | SARNS EVACUPLEGE CATHETER 3M Health Care, Sarns | DWF |
| Aug 10, 1984 | K842044 | SARNS EVACUPLEGE CATHETER 3M Health Care, Sarns | DWE |
| Apr 17, 1984 | K834134 | SARNS 8.0 SOFT ARC CANNULA 3M Health Care, Sarns | DWF |
| Jan 3, 1984 | K834025 | SARNS CARDIOPLEGIA CANNULA Y 3M Health Care, Sarns | DWF |
| Oct 20, 1983 | K832417 | HYPOTHERMIC MYCARDIAL PROTECTION DEV 3M Health Care, Sarns | DTR |
Newest 50 of 76.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||