Identity
- Trade Name
- FloWire Doppler Guide Wire EUDAMEDFDA UDI
- Generic Name
- Blood flowmeter catheter, Doppler FDA UDI
- Device Name
- FloWire EUDAMED
- Model / Reference
- 1400J EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1400J FDA UDI
- Primary DI / UDI-DI
- 00184360000129 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00184360000129 EUDAMED
- 510(k) Number
- K972762 FDA UDI
- FDA Product Code
- DQX FDA UDI
- EMDN Code
- C04030101 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
- GMDN Term
- Blood flowmeter catheter, Doppler 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
FloWire Doppler 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-00184360000129 | 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 3bb03f8c-6c0c-4a0d-a452-27882f2bdb59 61 fields · synced Jul 14, 2026
- FDA UDI c1b3df79-e31f-46d4-aaa9-4254ec3da923 35 fields · synced May 29, 2026