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Verrata Pressure Guide Wire
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref 10300
Identity
- Trade Name
- Verrata Pressure Guide Wire EUDAMEDVerrata Pressure Guide Wire 300cm FDA UDI
- Generic Name
- Catheter-tip transducer, pressure FDA UDI
- Device Name
- Verrata EUDAMED
- Model / Reference
- 10300 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845225002459 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225002459 EUDAMED
- 510(k) Number
- K131288 FDA UDI
- FDA Product Code
- DXO FDA UDIDQX FDA UDI
- EMDN Code
- C04030101 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
- GMDN Term
- Catheter-tip transducer, pressure FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2870 FDA UDI870.1330 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
Verrata Pressure Guide Wire by Volcano Corporation — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131288 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00845225002459 | Class III | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (3)
- EUDAMED 4167c779-6aa1-4c45-89a7-5f4d05c2041d 61 fields · synced Sep 30, 2026
- FDA UDI 1bbb2235-c631-4828-aeee-399784e981d1 33 fields · synced May 30, 2026
- FDA 510(k) K131288 1 fields · synced May 18, 2026