← Back to catalogue
CORE M2 Vascular System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 400-0100.17510(k) K170385
Identity
- Trade Name
- CORE M2 Vascular System EUDAMEDFDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Device Name
- Core M2 EUDAMED
- Model / Reference
- 400-0100.17 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 400-0100.17 FDA UDI
- Primary DI / UDI-DI
- 00845225012663 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225012663 EUDAMED
- 510(k) Number
- K170385 FDA UDI
- FDA Product Code
- DSA FDA UDIIYO FDA UDI
- EMDN Code
- C010499 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER EUDAMED
- GMDN Term
- Cardiovascular ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI892.1560 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CORE M2 Vascular System by Volcano Corporation — Class IIa — 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 | K170385 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00845225012663 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (3)
- EUDAMED abf61501-a693-44dc-bd0b-751865450ba8 85 fields · synced Jun 18, 2026
- FDA UDI 2a5f7799-5481-45d1-b6fa-3ca89a97fcac 35 fields · synced May 30, 2026
- FDA 510(k) K170385 1 fields · synced May 18, 2026