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Extracorporeal Medical Specialities, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
69
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORNovember 29, 1984
K840532HEMOPERFUSION SYSTEM TP-400May 30, 1984
K840262HANCOCK PERICARDIAL PATCHMay 30, 1984
K840146EXP* 700 PARALLEL PLATE DIALYZERFebruary 4, 1984
K840057EXP* 500 PARALLEL PLATE DIALYZERFebruary 4, 1984
K831423THERAPEUTIC EXCHANGE SYSTEMJanuary 3, 1984
K832547ULTRAFILTRATION CONTROLLERJanuary 3, 1984
K833477INTERSEPT 40 MICRON FILTERDecember 27, 1983
K833476INTERSEPT 40 MICRON FILTER W/TUBINGDecember 27, 1983
K831424THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101October 14, 1983
K832053SINGLE PATIENT SYS. II MODEL DM-450September 29, 1983
K830863HANCOCK PERICARDIAL PATCHAugust 31, 1983
K831029HEMOPERFUSION SYSTEM TP-400August 26, 1983
K830908BICARBONATE/VARIABLE SODIUM KIT-DM-367June 8, 1983
K831433EXTRASENSR ULTRAFILTRATION MONITORJune 2, 1983
K822339KF-101-13 DIALYZERFebruary 16, 1983
K822338KF-101-10 DIALYZERFebruary 16, 1983
K822337KF-101-07 DIALYZERFebruary 16, 1983
K823752EXTRACORPOREAL SUBCLAVIAN CATHETER KITJanuary 14, 1983
K823108INTERSEPT PEDIACTRIC EXTRACORPOREAL FILTNovember 30, 1982