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Phoenix 2.2mm x 130cm 6F Atherectomy System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P22130K
Identity
- Trade Name
- Phoenix 2.2mm x 130cm 6F Atherectomy System EUDAMEDFDA UDI
- Generic Name
- Mechanical atherectomy system catheter, peripheral FDA UDI
- Device Name
- Phoenix Atherectomy System EUDAMED
- Model / Reference
- P22130K EUDAMEDFDA UDI
Identifiers
- Catalog Number
- P22130K FDA UDI
- Primary DI / UDI-DI
- 00845225002701 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225002701 EUDAMED
- FDA Product Code
- MCW FDA UDI
- EMDN Code
- C010402020602 PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL EUDAMED
- GMDN Term
- Mechanical atherectomy system catheter, peripheral FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4875 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.2 Millimeter FDA UDILength — 130 Centimeter FDA UDI
Phoenix 2.2mm x 130cm 6F Atherectomy System by Volcano AtheroMed Inc. — Class IIa — 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-00845225002701 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Volcano AtheroMed Inc.
- EUDAMED SRN
- US-MF-000006912
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (2)
- EUDAMED 0a92c1df-6b8b-476e-8128-0f3ddcb01fff 61 fields · synced Jul 19, 2026
- FDA UDI 3d229598-5169-4504-bec6-38d3e90d98e4 36 fields · synced May 30, 2026