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Refinity ST Rotational IVUS Catheter
EUDAMEDFDA UDIClass III (EU MDR)
Ref 89900
Identity
- Trade Name
- Refinity ST Rotational IVUS Catheter EUDAMEDFDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, single-use FDA UDI
- Device Name
- Refinity EUDAMED
- Model / Reference
- 89900 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 89900 FDA UDI
- Primary DI / UDI-DI
- 00845225002831 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225002831 EUDAMED
- 510(k) Number
- K160583 FDA UDI
- FDA Product Code
- OBJ FDA UDIITX FDA UDI
- EMDN Code
- C0104020102 INTRAVASCULAR ULTRASOUND CATHETERS EUDAMED
- GMDN Term
- Intravascular ultrasound imaging catheter, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 FDA UDI892.1570 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 135 Centimeter FDA UDI
Refinity ST Rotational IVUS Catheter by Volcano Corporation — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00845225002831 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (2)
- EUDAMED 9eea7ebb-cc21-43e3-8857-9585ec7f9398 61 fields · synced Jul 19, 2026
- FDA UDI 22c618a6-23fe-483e-bf5b-3327e0f1a6b6 37 fields · synced May 25, 2026