Company ยท US
Extracorporeal Medical Specialities, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1984. Name variants (Inc, Corp, punctuation) are merged.
69510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | 11 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 6 |
| FJG | Dialyzer, Parallel Flow | 4 |
| FKP | System, Dialysate Delivery, Single Patient | 4 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 4 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 3 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 3 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 2 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 |
| FLD | Apparatus, Hemoperfusion, Sorbent | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 |
| DTB | Permanent Pacemaker Electrode | 1 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 1 |
| DXE | Catheter, Embolectomy | 1 |
| FIF | Set, Dialysis, Single Needle With Uni-Directional Pump | 1 |
| FIJ | System, Dialysate Delivery, Recirculating, Single Pass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 29, 1984 | K843955 | EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR Extracorporeal Medical Specialities, Inc. | DTZ |
| May 30, 1984 | K840532 | HEMOPERFUSION SYSTEM TP-400 Extracorporeal Medical Specialities, Inc. | FLD |
| May 30, 1984 | K840262 | HANCOCK PERICARDIAL PATCH Extracorporeal Medical Specialities, Inc. | DXZ |
| Feb 4, 1984 | K840146 | EXP* 700 PARALLEL PLATE DIALYZER Extracorporeal Medical Specialities, Inc. | KOC |
| Feb 4, 1984 | K840057 | EXP* 500 PARALLEL PLATE DIALYZER Extracorporeal Medical Specialities, Inc. | KOC |
| Jan 3, 1984 | K832547 | ULTRAFILTRATION CONTROLLER Extracorporeal Medical Specialities, Inc. | KDI |
| Jan 3, 1984 | K831423 | THERAPEUTIC EXCHANGE SYSTEM Extracorporeal Medical Specialities, Inc. | LQQ |
| Dec 27, 1983 | K833477 | INTERSEPT 40 MICRON FILTER Extracorporeal Medical Specialities, Inc. | DTM |
| Dec 27, 1983 | K833476 | INTERSEPT 40 MICRON FILTER W/TUBING Extracorporeal Medical Specialities, Inc. | DTM |
| Oct 14, 1983 | K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 Extracorporeal Medical Specialities, Inc. | FJK |
| Sep 29, 1983 | K832053 | SINGLE PATIENT SYS. II MODEL DM-450 Extracorporeal Medical Specialities, Inc. | KOC |
| Aug 31, 1983 | K830863 | HANCOCK PERICARDIAL PATCH Extracorporeal Medical Specialities, Inc. | DXZ |
| Aug 26, 1983 | K831029 | HEMOPERFUSION SYSTEM TP-400 Extracorporeal Medical Specialities, Inc. | FLD |
| Jun 8, 1983 | K830908 | BICARBONATE/VARIABLE SODIUM KIT-DM-367 Extracorporeal Medical Specialities, Inc. | FKQ |
| Jun 2, 1983 | K831433 | EXTRASENSR ULTRAFILTRATION MONITOR Extracorporeal Medical Specialities, Inc. | KOC |
| Feb 16, 1983 | K822339 | KF-101-13 DIALYZER Extracorporeal Medical Specialities, Inc. | KOC |
| Feb 16, 1983 | K822338 | KF-101-10 DIALYZER Extracorporeal Medical Specialities, Inc. | KOC |
| Feb 16, 1983 | K822337 | KF-101-07 DIALYZER Extracorporeal Medical Specialities, Inc. | KOC |
| Jan 14, 1983 | K823752 | EXTRACORPOREAL SUBCLAVIAN CATHETER KIT Extracorporeal Medical Specialities, Inc. | FIQ |
| Nov 30, 1982 | K823108 | INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT Extracorporeal Medical Specialities, Inc. | DTM |
| Nov 24, 1982 | K823205 | EXV VENOUS RESERVOIR BAG & HOLDER Extracorporeal Medical Specialities, Inc. | DTN |
| Nov 3, 1982 | K822340 | EXTRACORPOREAL SINGLE NEEDLE MODULE Extracorporeal Medical Specialities, Inc. | KOC |
| Oct 13, 1982 | K822385 | EXTRAPURE REVERSE OSMOSIS WATER UNIT Extracorporeal Medical Specialities, Inc. | FIP |
| Sep 24, 1982 | K822738 | TRIEX-IH DIALYZER Extracorporeal Medical Specialities, Inc. | KOC |
| Aug 27, 1982 | K822283 | TS-000 ARTERIOVENOUS BLOOD TUBING SET Extracorporeal Medical Specialities, Inc. | KOC |
| Jul 8, 1982 | K820600 | HANCOCK VASCULAR GRAFT Extracorporeal Medical Specialities, Inc. | DSY |
| Jun 2, 1982 | K821216 | INTERPULSE MEMBRANE OXYGENATOR Extracorporeal Medical Specialities, Inc. | DTZ |
| May 10, 1982 | K821139 | SPS-SINGLE PATIENT SYSTEM Extracorporeal Medical Specialities, Inc. | FIR |
| May 10, 1982 | K821138 | TS-180 SERIES TUBING SET Extracorporeal Medical Specialities, Inc. | FJK |
| Feb 5, 1982 | K820169 | MALE LUER CONNECTOR & HINGED CAP Extracorporeal Medical Specialities, Inc. | FJK |
| Jan 28, 1982 | K813205 | INTERSEPT CARDIOTOMY RESERVOIR/FILTER Extracorporeal Medical Specialities, Inc. | DTB |
| Nov 16, 1981 | K811972 | EXTRASENSR ULTRAFILTRATION MONITOR Extracorporeal Medical Specialities, Inc. | FKP |
| Jun 23, 1981 | K811444 | MODEL DM-333 DIALYSIS CONTROL STATION Extracorporeal Medical Specialities, Inc. | FKQ |
| Jun 12, 1981 | K811440 | EXP 600 PARALLEL PLATE DIALYZER Extracorporeal Medical Specialities, Inc. | FJG |
| Jun 12, 1981 | K811439 | EXP 200 PARALLEL PLATE DIALYZER Extracorporeal Medical Specialities, Inc. | FJG |
| Jun 2, 1981 | K811292 | PARALLEL PLATE DIALYZER HOLDER Extracorporeal Medical Specialities, Inc. | FKI |
| Jan 29, 1981 | K802364 | EXTRACORPOREAL'S EXP 400 PARALLEL PLATE Extracorporeal Medical Specialities, Inc. | FJG |
| Jan 22, 1981 | K803003 | INTERPULSE MEMBRANE OXYGENATION SYSTEM Extracorporeal Medical Specialities, Inc. | DTZ |
| Dec 22, 1980 | K803059 | INTERSEPT* VENOUS RESERVOIR BAG & HOLDER Extracorporeal Medical Specialities, Inc. | DTN |
| Dec 17, 1980 | K802880 | EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS Extracorporeal Medical Specialities, Inc. | FKP |
| Nov 25, 1980 | K802874 | ARTERIOVENOUS BLOOD TUBING SETS Extracorporeal Medical Specialities, Inc. | FJK |
| Jul 21, 1980 | K801344 | EXTRACORPOREALS' ALTERNATE MEMBRANE Extracorporeal Medical Specialities, Inc. | FJI |
| May 20, 1980 | K800771 | MOD. DM-356 IPS INTERFACE MODULE Extracorporeal Medical Specialities, Inc. | FKQ |
| May 14, 1980 | K800772 | MOD. DM-357 BICARBONATE RETROFIT KIT Extracorporeal Medical Specialities, Inc. | FKR |
| Apr 10, 1980 | K800549 | MODEL TRIEX-L HOLLOW FIBER DIALYZER Extracorporeal Medical Specialities, Inc. | FJI |
| Feb 26, 1980 | K800270 | TRIEX-2 HOLLOW FIBER DIALYZER Extracorporeal Medical Specialities, Inc. | FJI |
| Feb 21, 1980 | K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. Extracorporeal Medical Specialities, Inc. | DWE |
| Nov 16, 1979 | K792174 | MODEL DM 353 & DM-353-L SINGLE NEEDLE Extracorporeal Medical Specialities, Inc. | FIF |
| Nov 16, 1979 | K792173 | MODELS DM-360 & DM-350-L SINGLE PATIENT Extracorporeal Medical Specialities, Inc. | FKP |
| Nov 13, 1979 | K791961 | EXTRACORPOREAL'S MODEL EX-85 DIALYZER Extracorporeal Medical Specialities, Inc. | FJG |
Newest 50 of 69.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||