Medical Device Manufacturer · US , Mchenry , IL

Extracorporeal Medical Specialities, Inc. - FDA 510(k) Cleared Devices

69 submissions · 69 cleared · Since 1976

Recent clearances: EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR, HANCOCK PERICARDIAL PATCH, HEMOPERFUSION SYSTEM TP-400

69

Total

69

Cleared

0

Denied

FDA 510(k) Regulatory Record - Extracorporeal Medical Specialities, Inc. Cardiovascular ✕

15 devices

1-12 of 15

Cleared Nov 29, 1984

EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR

Cardiovascular · 51d

Cleared May 30, 1984

HANCOCK PERICARDIAL PATCH

Cardiovascular · 132d

Cleared Dec 27, 1983

INTERSEPT 40 MICRON FILTER W/TUBING

Cardiovascular · 81d

Cleared Dec 27, 1983

INTERSEPT 40 MICRON FILTER

Cardiovascular · 81d

Cleared Aug 31, 1983

HANCOCK PERICARDIAL PATCH

Cardiovascular · 166d

Cleared Nov 30, 1982

INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT

Cardiovascular · 40d

Cleared Nov 24, 1982

EXV VENOUS RESERVOIR BAG & HOLDER

Cardiovascular · 28d

Cleared Jul 08, 1982

HANCOCK VASCULAR GRAFT

Cardiovascular · 126d

Cleared Jun 02, 1982

INTERPULSE MEMBRANE OXYGENATOR

Cardiovascular · 36d

Cleared Jan 28, 1982

INTERSEPT CARDIOTOMY RESERVOIR/FILTER

Cardiovascular · 76d

Cleared Jan 22, 1981

INTERPULSE MEMBRANE OXYGENATION SYSTEM

Cardiovascular · 57d

Cleared Dec 22, 1980

INTERSEPT* VENOUS RESERVOIR BAG & HOLDER

Cardiovascular · 19d