Medical Device Manufacturer · US , Mchenry , IL

Uresil Corp. - FDA 510(k) Cleared Devices

45 submissions · 44 cleared · Since 1981

45

Total

44

Cleared

0

Denied

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

14 devices

1-12 of 14

Cleared Nov 20, 1998

URESIL VASCU-FLO INFUSION CATHETER

Cardiovascular · 298d

Cleared Apr 24, 1998

URESIL DILATOR WITH RADIOPAQUE MARKER

Cardiovascular · 88d

Cleared Jul 10, 1995

URESIL(R) GUIDEWIRE

Cardiovascular · 217d

Cleared Sep 21, 1994

Cardiovascular · 140d

Cleared May 26, 1993

URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS

Cardiovascular · 142d

Cleared Apr 18, 1991

URESIL VALVE CUTTER

Cardiovascular · 129d

Cleared Sep 25, 1987

MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN

Cardiovascular · 73d

Cleared Apr 22, 1987

URESIL CAROTID ARTERY SIZERS

Cardiovascular · 30d

Cleared Jan 06, 1987

URESIL SUBCLAVIAN CATHETER

Cardiovascular · 109d

Cleared Jan 02, 1987

EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER

Cardiovascular · 79d

Cleared Nov 24, 1986

URESIL CAROTID SHUNT

Cardiovascular · 73d

Cleared Oct 10, 1986

URESIL OCCLUSION BALLOON CATHETER

Cardiovascular · 28d