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Turbo-Elite Laser Atherectomy Catheter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 425-011Ref 414-151Ref 423-001
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
- 425-011 EUDAMEDFDA UDI423-001 EUDAMEDFDA UDI414-151 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 423-001 FDA UDI414-151 FDA UDI425-011 FDA UDI
- Primary DI / UDI-DI
- 00813132024789 EUDAMEDFDA UDI00813132024772 EUDAMEDFDA UDI00813132024710 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132024789 EUDAMEDB-00813132024710 EUDAMEDB-00813132024772 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 — 2.3 Millimeter FDA UDILength — 125 Centimeter FDA UDIOuter Diameter — 1.40 Millimeter FDA UDILength — 150 Centimeter FDA UDIOuter Diameter — 2.6 Millimeter FDA UDILength — 112 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-00813132024789 | 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 (6)
- EUDAMED 46cb1a77-040c-4114-bedf-87e1e66fa9c4 61 fields · synced Jul 20, 2026
- FDA UDI cc78f663-7ece-4e35-8624-380ef2a4f73a 36 fields · synced May 30, 2026
- FDA UDI 1f066251-5df4-4f76-a9bb-7c13ae1bb87d 36 fields · synced May 30, 2026
- FDA UDI 108e4395-c501-4262-b113-31ae7ecf4055 36 fields · synced May 30, 2026
- EUDAMED d7f3f32d-b8ca-473b-9269-f94c6e9c5949 61 fields · synced Jul 15, 2026
- EUDAMED 08e4bdf3-ec79-4740-bbad-a7ca6cd9c4be 61 fields · synced Jul 20, 2026