Creagh Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K230191Arise™ UHP Dilatation CatheterMarch 22, 2023
K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation CathetMay 14, 2020
K180007018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterApril 19, 2018
K171251014 Hydrophilic Coated PTA Balloon Dilatation CatheterSeptember 8, 2017
K113468ELM PTA BALLON DILATATION CATHETERDecember 20, 2011
K102645WILLOW/ELM PTA BALLOON DILATATION CATHETERDecember 10, 2010