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ELCA Coronary Laser Atherectomy Catheter
EUDAMEDFDA UDIClass III (EU MDR)
Ref 110-002
Identity
- Trade Name
- ELCA Coronary Laser Atherectomy Catheter EUDAMEDFDA UDI
- Generic Name
- Atherectomy laser system beam guide-catheter, coronary FDA UDI
- Device Name
- ELCA Coronary Laser Atherectomy Catheter EUDAMED
- Model / Reference
- 110-002 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 110-002 FDA UDI
- Primary DI / UDI-DI
- 00813132025472 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132025472 EUDAMED
- FDA Product Code
- LPC FDA UDI
- EMDN Code
- C010401020499 CORONARY ARTERY ATHERECTOMY SYSTEMS - OTHER EUDAMED
- GMDN Term
- Atherectomy laser system beam guide-catheter, coronary FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA 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 — 0.97 Millimeter FDA UDILength — 135 Centimeter FDA UDI
ELCA Coronary Laser Atherectomy Catheter by Spectranetics Corporation — Class III — 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-00813132025472 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | 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 d740a744-b1c4-4625-ac56-26e7baa22972 61 fields · synced Jul 18, 2026
- FDA UDI 743ee9df-ae1d-4ffe-b68c-ce3e89abfd5c 36 fields · synced May 29, 2026