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Turbo-Power Laser Atherectomy Catheter
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 423-050510(k) K152181Ref 420-050
Identity
- Trade Name
- Turbo-Power Laser Atherectomy Catheter EUDAMEDFDA UDI
- Generic Name
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
- Device Name
- Turbo-Power Laser Atherectomy Catheter EUDAMED
- Model / Reference
- 423-050 EUDAMEDFDA UDI420-050 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 420-050 FDA UDI423-050 FDA UDI
- Primary DI / UDI-DI
- 00813132026776 EUDAMEDFDA UDI00813132026783 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132026776 EUDAMEDB-00813132026783 EUDAMED
- FDA Product Code
- MCW FDA UDI
- EMDN Code
- C010402020602 PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL EUDAMED
- GMDN Term
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
Classification
- Device Class
- Class IIb 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 UDIOuter Diameter — 2.3 Millimeter FDA UDILength — 125 Centimeter FDA UDI
Turbo-Power Laser Atherectomy Catheter by Spectranetics Corporation — Class IIb — 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 | K152181 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00813132026776 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- FDA Applicant
- Spectranetics, Inc.
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (5)
- EUDAMED 08fef6a8-e020-4857-b5fe-74919f71c388 85 fields · synced Jul 19, 2026
- FDA UDI 13ec4ace-4a8e-4ea9-815e-7df14adef786 36 fields · synced May 30, 2026
- FDA UDI 38f0832d-18fb-45a0-896c-fd63b49ea2e3 36 fields · synced May 30, 2026
- EUDAMED a1956227-ffe8-4e08-b942-7f628cacf79f 61 fields · synced Jul 19, 2026
- FDA 510(k) K152181 1 fields · synced May 18, 2026