Medical Device Manufacturer · US , Mchenry , IL

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

56 submissions · 56 cleared · Since 1976

56

Total

56

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared May 25, 1979

PURGE LINE UNIT

Cardiovascular · 31d

Cleared Mar 27, 1979

INTERSEPT* BLOOD FILTER W/ TUBING BYPASS

Cardiovascular · 42d

Cleared Nov 15, 1978

FILTER, EXTRACORPOREAL BLOOD HOLDER

Cardiovascular · 9d

Cleared Oct 26, 1978

FILTER, ARTERIAL BLOOD W/TUBING BYPASS

Cardiovascular · 16d