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

Transducer, Pressure, Catheter Tip (DXO) (3) Wire, Guide, Catheter (DQX) (3) Catheter, Intravascular, Diagnostic (DQO) (1) Catheter, Ultrasound, Intravascular (OBJ) (1)

Premarket Exempt

Clear

Verrata Pressure Guide Wire 185cm JTIP - 00845225002442 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

Verrata Pressure Guide Wire 300cm - 00845225002459 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

Verrata Pressure Guide Wire 300cm JTIP - 00845225002466 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DQX, DXO

Prescription Use : Yes

Device Count : 1

Refinity Rotational Intravascular Ultrasound IVUS Catheter - 00845225002824 Catalog Number :

Device Class : 2

Duns Number: 853202646

Premarket Exempt : No

Product Code : DQO, OBJ

Prescription Use : Yes

Device Count : 1

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