VOLCANO CORPORATION

Address:2451 Mercantile Drive,Rancho Cordova,CA,95742,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Echo, Ultrasonic (IYO) (8) Cable, Transducer And Electrode, Patient, (Including Connector) (DSA) (4) Computer, Blood-Pressure (DSK) (3) Catheter, Ultrasound, Intravascular (OBJ) (2) Interventional Fluoroscopic X-Ray System (OWB) (1) Wire, Guide, Catheter (DQX) (1)

Premarket Exempt

Clear

CORE (W/X9 M/B), PC WORKSTATION FRU - 00845225012724 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : IYO, DSK, DSA

Prescription Use : Yes

Device Count : 1

SmartMap Pressure System - 00845225012731 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Connection Box II - 00845225012748 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

PIM, SYNTHETIC APERTURE W/PIGTAIL, s5 - 00845225012755 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : OBJ, IYO

Prescription Use : Yes

Device Count : 1

PIM, SYNTHETIC APERTURE W/PIGTAIL - 00845225012762 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : IYO, OBJ

Prescription Use : Yes

Device Count : 1

CORE M2, Cart - 00845225012786 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : DSA, IYO

Prescription Use : Yes

Device Count : 1

CORE PC WORKSTATION FRU - 00845225012809 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

CORE Control Pad 2.0 - 00845225012823 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : DSA, DSK, IYO

Prescription Use : Yes

Device Count : 1

SyncVision Workstation - 00845225012830 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : OWB

Prescription Use : Yes

Device Count : 1

FM-PIM - 00845225012847 Catalog Number : 797416

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : DSK, DSA, IYO

Prescription Use : Yes

Device Count : 1

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