Identity
- Trade Name
- ComboWire Pressure/Flow Guide Wire EUDAMEDComboWire Pressure/Flow Guide Wire XT FDA UDI
- Generic Name
- Intravascular haemodynamic monitoring system guidewire FDA UDI
- Device Name
- ComboWire EUDAMED
- Model / Reference
- 9500 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00184360000341 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00184360000341 EUDAMED
- 510(k) Number
- K042996 FDA UDI
- FDA Product Code
- DQX FDA UDI
- EMDN Code
- C04030101 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
- GMDN Term
- Intravascular haemodynamic monitoring system guidewire FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1330 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ComboWire Pressure/Flow Guide Wire 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-00184360000341 | 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 15334225-ee49-4481-8930-71735c024396 61 fields · synced Jul 8, 2026
- FDA UDI bc5f5cd2-aac1-4852-a40c-63ccebd10b49 33 fields · synced May 25, 2026