Medical Device Manufacturer · US , Mchenry , IL

Sontek Corp. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1981

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sontek Corp. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jun 30, 1983

SONTEK INFUSION CATHETER

Cardiovascular · 45d

Cleared Apr 17, 1981

SONTEK ANGIOGRAPHIC CATHETER

Cardiovascular · 52d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Apr 28, 2026