3M Health Care, Sarns
Mchenry, IL, US
3M Health Care, Sarns appears in FDA device records in Mchenry, IL. FDA records list 76 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 76
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 76FDA records hold 76 510(k) clearances for 3M Health Care, Sarns between 1976 and 1996. The busiest year on record is 1977, with 7. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 7 |
| 1978 | 4 |
| 1979 | 2 |
| 1980 | 3 |
| 1981 | 3 |
| 1982 | 3 |
| 1983 | 4 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 7 |
| 1987 | 4 |
| 1988 | 6 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 7 |
| 1992 | 3 |
| 1993 | 6 |
| 1994 | 6 |
| 1995 | 1 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K960916 | SAMS 8000 CARDIOPLEGIA MONITOR | DSJ | Substantially Equivalent | |
| K953901 | SARNS 800 ROLLER PUMP | DWB | Substantially Equivalent | |
| K950739 | 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM | DWA | Substantially Equivalent | |
| K941653 | SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION | DTZ | Substantially Equivalent | |
| K941654 | SARNS FILTERED VENOUS RESERVIOR MODIFICATION | DTP | Substantially Equivalent | |
| K940651 | SARNS ULTRASONIC AIR SENSOR | KRL | Substantially Equivalent | |
| K935391 | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK | GFA | Substantially Equivalent | |
| K934127 | SARNS LOW JETTING AORTIC ARCH CANNULA | DWF | Substantially Equivalent | |
| K935977 | SARNS AIR DETECTION SYSTEM | KRL | Substantially Equivalent | |
| K915547 | SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT | KFM | Substantially Equivalent | |
| K925076 | SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R. | DTZ | Substantially Equivalent | |
| K925075 | SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR | DTZ | Substantially Equivalent | |
| K925442 | SARNS RETROGRADE CANNULA | DWF | Substantially Equivalent | |
| K920902 | MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA | DWF | Substantially Equivalent | |
| K922471 | SARNS RETROGRADE CANNULA - AUTO INFLATE | DWF | Substantially Equivalent | |
| K923311 | CONDUCER HEAT EXCHANGER | DTR | Substantially Equivalent | |
| K915183 | SARNS 8000 MODULAR PERFUSION SYSTEM | DTQ | Substantially Equivalent | |
| K915193 | SARNS RETROGRADE CANNULA | DWF | Substantially Equivalent | |
| K913176 | DELPHIN II CENTRIFUGAL SYSTEM | KFM | Substantially Equivalent | |
| K912079 | SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY | DTZ | Substantially Equivalent | |
| K912078 | SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION | DTZ | Substantially Equivalent | |
| K911227 | NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS | DTZ | Substantially Equivalent | |
| K905686 | SARNS TEMPERATURE PROBE AND CONNECTOR | DWE | Substantially Equivalent | |
| K905224 | CARDIOPULMONARY BYPASS VASCULAR CATHETER | DWF | Substantially Equivalent | |
| K905638 | SARNS INVENT CATHETERS | DWF | Substantially Equivalent | |
| K903436 | SARNS MEMBRANE OXGENATOR PART NUMBER 9443 | DTZ | Substantially Equivalent | |
| K884659 | SARNS 9000 WITH CENTRIFUGAL PUMP OPTION | KFM | Substantially Equivalent | |
| K883071 | SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM | DTR | Substantially Equivalent | |
| K883603 | SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) | DWC | Substantially Equivalent | |
| K882758 | CENTRIFUGAL PUMP SYSTEM LX/DX VERSION | KFM | Substantially Equivalent | |
| K883345 | SARNS INFANT VENOUS RESERVOIR MODEL #16387 | DTN | Substantially Equivalent | |
| K875048 | SARNS VENOATRIAL CATHETER | DWF | Substantially Equivalent | |
| K874896 | SARNS VISIFLOW AORTIC ARCH CANNULA | DWF | Substantially Equivalent | |
| K873813 | SARNS WARMER, PART #164975 AND #164980 | DWC | Substantially Equivalent | |
| K873212 | SARNS CARDIOPLEGIA/VENT CATHETERS | DWF | Substantially Equivalent | |
| K871131 | SARNS 9000 HEART-LUNG CONSOLE | DTQ | Substantially Equivalent | |
| K870829 | SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR | DTN | Substantially Equivalent | |
| K863902 | MODIFIED SARNS MEMBRANE OXYGENATOR | DTX | Substantially Equivalent | |
| K863593 | SARNS SAFETY LOOP | DWD | Substantially Equivalent | |
| K863515 | MODIFIED SARNS OXYGENATOR SYSTEM | DTZ | Substantially Equivalent | |
| K862357 | MODIFIED CARDIOTOMY RESERVOIR 5M1470 | DTN | Substantially Equivalent | |
| K861388 | SARNS PORTABLE POWER MODULE | DTQ | Substantially Equivalent | |
| K860702 | SARNS FILTERED CARDIOTOMY RESERVOIR | DTP | Substantially Equivalent | |
| K860539 | SARNS OXYGENATOR SYSTEM | DTZ | Substantially Equivalent | |
| K853516 | SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM | DTR | Substantially Equivalent | |
| K853128 | SARNS EVACUPLEGE CATHETER | DWF | Substantially Equivalent | |
| K842044 | SARNS EVACUPLEGE CATHETER | DWE | Substantially Equivalent | |
| K834134 | SARNS 8.0 SOFT ARC CANNULA | DWF | Substantially Equivalent | |
| K834025 | SARNS CARDIOPLEGIA CANNULA Y | DWF | Substantially Equivalent | |
| K832417 | HYPOTHERMIC MYCARDIAL PROTECTION DEV | DTR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DSJAlarm, Blood-Pressure
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- HRXArthroscope
- GFABlade, Saw, General & Plastic Surgery, Surgical
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- KPLColonic Irrigation System
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- DWCController, Temperature, Cardiopulmonary Bypass
- DTPDefoamer, Cardiopulmonary Bypass
- KRLDetector, Bubble, Cardiopulmonary Bypass
- DTXGas Control Unit, Cardiopulmonary Bypass
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- KDCInstrument, Surgical, Disposable
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
- FIRPump, Blood, Extra-Luminal
- DTNReservoir, Blood, Cardiopulmonary Bypass
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass
- DWETubing, Pump, Cardiopulmonary Bypass
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain