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Phoenix 1.8mm x 149cm 5F Atherectomy System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref P18149K510(k) K172386
Identity
- Trade Name
- Phoenix 1.8mm x 149cm 5F Atherectomy System EUDAMEDFDA UDI
- Generic Name
- Mechanical atherectomy system catheter, peripheral FDA UDI
- Device Name
- Phoenix Atherectomy System EUDAMED
- Model / Reference
- P18149K EUDAMEDFDA UDI
Identifiers
- Catalog Number
- P18149K FDA UDI
- Primary DI / UDI-DI
- 00845225002725 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225002725 EUDAMED
- 510(k) Number
- K143328 FDA UDI
- 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 — 1.8 Millimeter FDA UDILength — 149 Centimeter FDA UDI
Phoenix 1.8mm x 149cm 5F Atherectomy System by Volcano AtheroMed Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K172386 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00845225002725 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Volcano AtheroMed Inc.
- EUDAMED SRN
- US-MF-000006912
- FDA Applicant
- Volcano Atheromed, Inc.
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (3)
- EUDAMED bc2b45ca-ee80-4ba0-83e7-34e38b43dba2 85 fields · synced Jun 18, 2026
- FDA UDI f8e44ca0-00c4-44b2-b9c4-c48aaef852fa 37 fields · synced May 29, 2026
- FDA 510(k) K172386 1 fields · synced Jun 9, 2026