Volcarica S.R.L.

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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) (9) Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty (OBL) (1) Transducer, Pressure, Catheter Tip (DXO) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

Clear

PrimeWire Prestige Plus Pressure Guide Wire 185cm ST - 00845225001100 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

PrimeWire Prestige Plus Pressure Guide Wire 185cm JTIP - 00845225001117 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

PrimeWire Prestige Plus Pressure Guide Wire 300cm ST - 00845225001124 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

PrimeWire Prestige Plus Pressure Guide Wire 300cm JTIP - 00845225001131 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

PrimeWire Prestige Pressure Guide Wire 185cm ST - 00845225001148 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

PrimeWire Prestige Pressure Guide Wire 185cm JTIP - 00845225001155 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

PrimeWire Prestige Pressure Guide Wire 300cm ST - 00845225001162 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

PrimeWire Prestige Pressure Guide Wire 300cm JTIP - 00845225001179 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Visions PV.014P RX Digital IVUS Catheter - 00845225002428 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : OBL, ITX

Prescription Use : Yes

Device Count : 1

Verrata Pressure Guide Wire 185cm - 00845225002435 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

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