Extracorporeal Medical Specialities, Inc.
Mchenry, IL, US
Extracorporeal Medical Specialities, Inc. appears in FDA device records in Mchenry, IL. FDA records list 69 510(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
- 69
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 69FDA records hold 69 510(k) clearances for Extracorporeal Medical Specialities, Inc. between 1976 and 1984. The busiest year on record is 1982, with 12. The most recent is 1984, with 7.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 5 |
| 1978 | 6 |
| 1979 | 9 |
| 1980 | 9 |
| 1981 | 7 |
| 1982 | 12 |
| 1983 | 12 |
| 1984 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K843955 | EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR | DTZ | Substantially Equivalent | |
| K840532 | HEMOPERFUSION SYSTEM TP-400 | FLD | Substantially Equivalent | |
| K840262 | HANCOCK PERICARDIAL PATCH | DXZ | Substantially Equivalent | |
| K840146 | EXP* 700 PARALLEL PLATE DIALYZER | KOC | Substantially Equivalent | |
| K840057 | EXP* 500 PARALLEL PLATE DIALYZER | KOC | Substantially Equivalent | |
| K832547 | ULTRAFILTRATION CONTROLLER | KDI | Substantially Equivalent | |
| K831423 | THERAPEUTIC EXCHANGE SYSTEM | LQQ | Substantially Equivalent | |
| K833477 | INTERSEPT 40 MICRON FILTER | DTM | Substantially Equivalent | |
| K833476 | INTERSEPT 40 MICRON FILTER W/TUBING | DTM | Substantially Equivalent | |
| K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 | FJK | Substantially Equivalent | |
| K832053 | SINGLE PATIENT SYS. II MODEL DM-450 | KOC | Substantially Equivalent | |
| K830863 | HANCOCK PERICARDIAL PATCH | DXZ | Substantially Equivalent | |
| K831029 | HEMOPERFUSION SYSTEM TP-400 | FLD | Substantially Equivalent | |
| K830908 | BICARBONATE/VARIABLE SODIUM KIT-DM-367 | FKQ | Substantially Equivalent | |
| K831433 | EXTRASENSR ULTRAFILTRATION MONITOR | KOC | Substantially Equivalent | |
| K822339 | KF-101-13 DIALYZER | KOC | Substantially Equivalent | |
| K822338 | KF-101-10 DIALYZER | KOC | Substantially Equivalent | |
| K822337 | KF-101-07 DIALYZER | KOC | Substantially Equivalent | |
| K823752 | EXTRACORPOREAL SUBCLAVIAN CATHETER KIT | FIQ | Substantially Equivalent | |
| K823108 | INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT | DTM | Substantially Equivalent | |
| K823205 | EXV VENOUS RESERVOIR BAG & HOLDER | DTN | Substantially Equivalent | |
| K822340 | EXTRACORPOREAL SINGLE NEEDLE MODULE | KOC | Substantially Equivalent | |
| K822385 | EXTRAPURE REVERSE OSMOSIS WATER UNIT | FIP | Substantially Equivalent | |
| K822738 | TRIEX-IH DIALYZER | KOC | Substantially Equivalent | |
| K822283 | TS-000 ARTERIOVENOUS BLOOD TUBING SET | KOC | Substantially Equivalent | |
| K820600 | HANCOCK VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K821216 | INTERPULSE MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K821139 | SPS-SINGLE PATIENT SYSTEM | FIR | Substantially Equivalent | |
| K821138 | TS-180 SERIES TUBING SET | FJK | Substantially Equivalent | |
| K820169 | MALE LUER CONNECTOR & HINGED CAP | FJK | Substantially Equivalent | |
| K813205 | INTERSEPT CARDIOTOMY RESERVOIR/FILTER | DTB | Substantially Equivalent | |
| K811972 | EXTRASENSR ULTRAFILTRATION MONITOR | FKP | Substantially Equivalent | |
| K811444 | MODEL DM-333 DIALYSIS CONTROL STATION | FKQ | Substantially Equivalent | |
| K811440 | EXP 600 PARALLEL PLATE DIALYZER | FJG | Substantially Equivalent | |
| K811439 | EXP 200 PARALLEL PLATE DIALYZER | FJG | Substantially Equivalent | |
| K811292 | PARALLEL PLATE DIALYZER HOLDER | FKI | Substantially Equivalent | |
| K802364 | EXTRACORPOREAL'S EXP 400 PARALLEL PLATE | FJG | Substantially Equivalent | |
| K803003 | INTERPULSE MEMBRANE OXYGENATION SYSTEM | DTZ | Substantially Equivalent | |
| K803059 | INTERSEPT* VENOUS RESERVOIR BAG & HOLDER | DTN | Substantially Equivalent | |
| K802880 | EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS | FKP | Substantially Equivalent | |
| K802874 | ARTERIOVENOUS BLOOD TUBING SETS | FJK | Substantially Equivalent | |
| K801344 | EXTRACORPOREALS' ALTERNATE MEMBRANE | FJI | Substantially Equivalent | |
| K800771 | MOD. DM-356 IPS INTERFACE MODULE | FKQ | Substantially Equivalent | |
| K800772 | MOD. DM-357 BICARBONATE RETROFIT KIT | FKR | Substantially Equivalent | |
| K800549 | MODEL TRIEX-L HOLLOW FIBER DIALYZER | FJI | Substantially Equivalent | |
| K800270 | TRIEX-2 HOLLOW FIBER DIALYZER | FJI | Substantially Equivalent | |
| K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. | DWE | Substantially Equivalent | |
| K792174 | MODEL DM 353 & DM-353-L SINGLE NEEDLE | FIF | Substantially Equivalent | |
| K792173 | MODELS DM-360 & DM-350-L SINGLE PATIENT | FKP | Substantially Equivalent | |
| K791961 | EXTRACORPOREAL'S MODEL EX-85 DIALYZER | FJG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- FLDApparatus, Hemoperfusion, Sorbent
- FIQCannula, A-V Shunt
- DXECatheter, Embolectomy
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- LQQColumns, Immunoadsorption In Extracorporeal Systems
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- FJGDialyzer, Parallel Flow
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- FJTIntracatheter, Dialysis
- DTZOxygenator, Cardiopulmonary Bypass
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- DTBPermanent Pacemaker Electrode
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- FIRPump, Blood, Extra-Luminal
- FRNPump, Infusion
- DTNReservoir, Blood, Cardiopulmonary Bypass
- FPASet, Administration, Intravascular
- FIFSet, Dialysis, Single Needle With Uni-Directional Pump
- FKISet, Dialyzer Holder
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FKRSubsystem, Proportioning
- FIPSubsystem, Water Purification
- FKQSystem, Dialysate Delivery, Central Multiple Patient
- FIJSystem, Dialysate Delivery, Recirculating, Single Pass
- FILSystem, Dialysate Delivery, Single Pass
- FKPSystem, Dialysate Delivery, Single Patient
- DRSTransducer, Blood-Pressure, Extravascular
- BTRTube, Tracheal (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- 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