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Turbo-Elite Laser Atherectomy Catheter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 420-006
Identity
- Trade Name
- Turbo-Elite Laser Atherectomy Catheter EUDAMEDFDA UDI
- Generic Name
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
- Device Name
- Turbo-Elite Laser Atherectomy Catheter EUDAMED
- Model / Reference
- 420-006 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 420-006 FDA UDI
- Primary DI / UDI-DI
- 00813132024758 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132024758 EUDAMED
- FDA Product Code
- MCW FDA UDI
- EMDN Code
- C010402020699 PERIPHERAL ATHERECTOMY SYSTEMS - OTHER EUDAMED
- GMDN Term
- Atherectomy laser system beam guide-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
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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.0 Millimeter FDA UDILength — 150 Centimeter FDA UDI
Turbo-Elite Laser Atherectomy Catheter by Spectranetics Corporation — 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-00813132024758 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (2)
- EUDAMED 2d33173c-be64-4d33-a75f-1023705a55e6 61 fields · synced Jun 1, 2026
- FDA UDI 3bfcab35-5f1c-4fd3-b754-4d4c25cd8590 36 fields · synced May 30, 2026