Creagh Medical, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Arise™ UHP Dilatation Catheter, Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter, 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Creagh Medical, Ltd. Cardiovascular ✕
5 devices
Cleared
Mar 22, 2023
Arise™ UHP Dilatation Catheter
Cardiovascular
57d
Cleared
May 14, 2020
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal...
Cardiovascular
58d
Cleared
Apr 19, 2018
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Cardiovascular
107d
Cleared
Dec 20, 2011
ELM PTA BALLON DILATATION CATHETER
Cardiovascular
28d
Cleared
Dec 10, 2010
WILLOW/ELM PTA BALLOON DILATATION CATHETER
Cardiovascular
88d