Volcano Corporation - FDA 510(k) Cleared Devices
55
Total
55
Cleared
0
Denied
FDA 510(k) cleared devices by Volcano Corporation Radiology ✕
28 devices
Cleared
Apr 12, 2019
SyncVision System
Radiology
32d
Cleared
Apr 11, 2018
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular...
Radiology
112d
Cleared
Oct 25, 2017
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software...
Radiology
72d
Cleared
Oct 05, 2017
SyncVision System
Radiology
38d
Cleared
Apr 06, 2017
CORE M2 Vascular System
Radiology
57d
Cleared
Sep 05, 2016
SyncVision System
Radiology
70d
Cleared
Dec 22, 2015
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install...
Radiology
29d
Cleared
Jul 31, 2015
SyncVision System
Radiology
18d
Cleared
Mar 20, 2015
Volcano iFR Modality, iFR Scout feature
Radiology
28d
Cleared
Feb 20, 2015
Volcano iFR Harvest Software (Offline)
Radiology
112d
Cleared
Mar 14, 2014
VOLCANO IFR MODALITY
Radiology
136d
Cleared
Mar 07, 2014
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR...
Radiology
30d