Identity
- Trade Name
- Phoenix Atherectomy System EUDAMEDPhoenix 1.8mm x 130cm 5F Atherectomy System FDA UDI
- Generic Name
- Mechanical atherectomy system catheter, peripheral FDA UDI
- Device Name
- Phoenix Atherectomy System EUDAMED
- Model / Reference
- P18130K EUDAMEDFDA UDI
Identifiers
- Catalog Number
- P18130K FDA UDI
- Primary DI / UDI-DI
- 00845225003814 EUDAMED00845225003548 FDA UDI
- Basic UDI-DI
- 08452250BM4066Z EUDAMED
- 510(k) Number
- K140944 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
- Netherlands 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.8 Millimeter FDA UDILength — 130 Centimeter FDA UDI
Phoenix Atherectomy System by Philips Image Guided Therapy Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08452250BM4066Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Image Guided Therapy Corporation
- EUDAMED SRN
- US-MF-000018632
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 9f212a26-331c-4c8a-83d0-9679c5d6a3c5 61 fields · synced Jul 14, 2026
- FDA UDI 09ebb831-1828-4ffe-a4ec-a8fd617d7f84 37 fields · synced May 30, 2026