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Refinity Rotational Intravascular Ultrasound IVUS Catheter

FDA UDI

Class II (US FDA UDI)

by Volcarica S.R.L.

Identity

Trade Name
Refinity Rotational Intravascular Ultrasound IVUS Catheter FDA UDI
Generic Name
Intravascular ultrasound imaging catheter, single-use FDA UDI
Model / Reference
89800 FDA UDI

Identifiers

Primary DI / UDI-DI
00845225002824 FDA UDI
510(k) Number
K160583 FDA UDI
FDA Product Code
DQO FDA UDI
OBJ FDA UDI
GMDN Term
Intravascular ultrasound imaging catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intravascular ultrasound imaging catheter, single-use

Refinity Rotational Intravascular Ultrasound IVUS Catheter by Volcarica S.R.L. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular ultrasound imaging catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Volcarica S.R.L.

Sources (1)

  • FDA UDI 404a6c2c-94f0-4fb1-8a02-1a13eff0ca24 33 fields · synced Jun 6, 2026