Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
Cardiocirculatory system devices
/
Arterio-venous system devices
/
Angiography and haemodynamic devices
/
Peripheral angiography devices
/
Peripheral angiography diagnostic devices
/
Intravascular ultrasound catheters
Intravascular ultrasound catheters
C0104020102
9 devices
Devices
Eagle Eye Platinum RX Digital IVUS Catheter
Volcano Corporation
·
,
US
Class III
FDA 510(k)
K092596
Active
Cleared 10 Dec 2009
CE/MDD
+1
authorizations
Pioneer Plus Catheter
Volcano Corporation
·
,
US
Class IIa
CE/MDD
GUDID
on market
Eagle Eye Platinum ST RX Digital IVUS Catheter
Volcano Corporation
·
,
US
Class III
FDA 510(k)
K120697
Active
Cleared 5 Apr 2012
CE/MDD
+1
authorizations
Visions PV .035 Digital IVUS Catheter
Open recall
Volcano Corporation
·
,
US
Class III
FDA 510(k)
K121273
Active
Cleared 10 Sep 2012
FDA 510(k)
K153094
Active
Cleared 31 Dec 2015
+2
authorizations
Refinity ST Rotational IVUS Catheter
Volcano Corporation
·
,
US
Class III
CE/MDD
GUDID
on market
Visions PV .014P RX Digital IVUS Catheter
Philips Image Guided Therapy Corporation
·
,
US
Class IIa
FDA 510(k)
K253399
Active
Cleared 28 Oct 2025
CE/MDR
+1
authorizations
Revolution 45MHz Rotational Imaging Catheter
Volcano Corporation
·
,
US
Class III
CE/MDD
GUDID
on market
OptiCross™ 18
Boston Scientific
·
,
US
Class IIa
CE/MDR
GUDID
on market
Visions PV .018 Digital IVUS Catheter
Open recall
Volcano Corporation
·
,
US
Class IIa
FDA 510(k)
K150442
Active
Cleared 4 Sep 2015
CE/MDD
+1
authorizations
Previous
Next