Medical Device Manufacturer · US , Mchenry , IL

Shiley, Inc. - FDA 510(k) Cleared Devices

174 submissions · 174 cleared · Since 1976

174

Total

174

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shiley, Inc. Cardiovascular ✕

120 devices

1-12 of 120

1 2 3 4

Cleared Mar 18, 1993

SHILEY PERFUSION TUBING SETS

Cardiovascular · 401d

Cleared Aug 09, 1991

SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200

Cardiovascular · 102d

Cleared Apr 09, 1991

Cardiovascular · 35d

Cleared Jul 03, 1990

SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.

Cardiovascular · 85d

Cleared Jun 11, 1990

PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR

Cardiovascular · 87d

Cleared Jun 11, 1990

PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR

Cardiovascular · 87d

Cleared May 10, 1990

STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR

Cardiovascular · 79d

Cleared Apr 10, 1990

BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET

Cardiovascular · 84d

Cleared Apr 10, 1990

SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)

Cardiovascular · 53d

Cleared Mar 28, 1990

MODIFIED SHILEY FEMORAL VENOUS CANNULA

Cardiovascular · 247d

Cleared Mar 28, 1990

HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES

Cardiovascular · 64d

Cleared Feb 28, 1990

DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR

Cardiovascular · 286d

1 2 3 4

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