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Quick-Cross Extreme Support Catheter
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref 518-078Ref 518-076Ref 518-092Ref 518-082Ref 518-080Ref 518-086
Identity
- Trade Name
- Quick-Cross Extreme Support Catheter EUDAMED
- Device Name
- Quick-Cross Extreme Support Catheter EUDAMED
- Model / Reference
- 518-078 EUDAMED518-076 EUDAMED518-092 EUDAMED518-082 EUDAMED518-080 EUDAMED518-086 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20813132021478 EUDAMED20813132022253 EUDAMED20813132021782 EUDAMED20813132021683 EUDAMED20813132021669 EUDAMED20813132021720 EUDAMED
- Basic UDI-DI
- B-20813132021478 EUDAMEDB-20813132022253 EUDAMEDB-20813132021782 EUDAMEDB-20813132021683 EUDAMEDB-20813132021669 EUDAMEDB-20813132021720 EUDAMED
- EMDN Code
- C0104020204 PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Quick-Cross Extreme Support Catheter by Spectranetics Corporation — Class III — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150201 | Class III | Active |
| EUDAMED | European Union | CE/MDR | B-20813132021478 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-20813132021478 | Class III | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (7)
- EUDAMED 9da5da36-1b8f-47af-aa33-e7fc07a601fd 61 fields · synced Jul 29, 2026
- EUDAMED 3e8babdb-8b95-4354-8259-38c14d50b301 61 fields · synced May 17, 2026
- EUDAMED 1b62f39d-30bf-40e4-b0cd-a7ef316af61f 61 fields · synced May 18, 2026
- EUDAMED 21f55344-9797-46f2-9f85-a5753c49edf2 61 fields · synced May 19, 2026
- EUDAMED 835c42fb-d990-4b35-99b6-1ab79043a0bc 61 fields · synced May 19, 2026
- EUDAMED 5b1d829f-680d-47ba-b295-7383cf52d465 61 fields · synced May 19, 2026
- FDA 510(k) K150201 1 fields · synced Jun 9, 2026