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

Wire, Guide, Catheter (DQX) (5) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (3) Catheter, Ultrasound, Intravascular (OBJ) (2) Filter, Intravascular, Cardiovascular (DTK) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

Clear

FloWire Doppler Guide Wire XT 175cm 014 JTIP - 00184360000167 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

FloWire Doppler Guide Wire XT 300cm 014 ST - 00184360000198 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

FloWire Doppler Guide Wire XT 300cm 014 JTIP - 00184360000204 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

R-100 Pullback Device - 00184360000327 Catalog Number : 804547001

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

ComboWire Pressure/Flow Guide Wrie XT 1.5cm Sensor - 00184360000334 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

ComboWire Pressure/Flow Guide Wire XT - 00184360000341 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

s5 PC Module - 00184360000525 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : IYO, OBJ

Prescription Use : Yes

Device Count : 1

s5i Imaging System Workstation - 00184360000686 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

s5i Control Console - 00184360000709 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : OBJ, IYO

Prescription Use : Yes

Device Count : 1

Crux® Vena Cava FIlter, Femoral - 00845225002527 Catalog Number :

Device Class : 2

Duns Number: 135179237

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

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