Medical Device Manufacturer · US , North Reading , MA

Usci Ireland - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2007

Recent clearances: OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER, OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Usci Ireland Cardiovascular ✕

2 devices

1-2 of 2

Cleared Nov 03, 2008

OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER

Cardiovascular · 53d

Cleared Nov 09, 2007

OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER

Cardiovascular · 98d