← Back to catalogue
Quick-Cross Support Catheter
EUDAMEDFDA UDIClass III (EU MDR)
Ref 518-032Ref 518-035Ref 518-038Ref 518-066Ref 518-033
Identity
- Trade Name
- Quick-Cross Support Catheter EUDAMEDFDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Quick-Cross Support Catheter EUDAMED
- Model / Reference
- 518-032 EUDAMED518-035 EUDAMED518-038 EUDAMED518-066 EUDAMEDFDA UDI518-033 EUDAMED
Identifiers
- Catalog Number
- 518-066 FDA UDI
- Primary DI / UDI-DI
- 20813132020631 EUDAMED20813132020662 EUDAMED20813132020693 EUDAMED20813132020709 EUDAMED20813132020648 EUDAMED00813132020705 FDA UDI
- Basic UDI-DI
- B-20813132020631 EUDAMEDB-20813132020662 EUDAMEDB-20813132020693 EUDAMEDB-20813132020709 EUDAMEDB-20813132020648 EUDAMED
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C0104020204 PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS EUDAMED
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 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
- Length — 65 Centimeter FDA UDILumen/Inner Diameter — 0.035 Inch FDA UDI
Quick-Cross Support Catheter by Spectranetics Corporation — Class III — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-20813132020631 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-20813132020631 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (6)
- EUDAMED 0c1b48fa-e1c7-479e-9a97-a92cf8434e14 61 fields · synced Jul 26, 2026
- EUDAMED 57a6ec9a-721a-42ee-ba52-12a32f85e5dc 61 fields · synced May 17, 2026
- EUDAMED 6e39b7c1-f993-4980-8b8f-be6491cd2219 61 fields · synced May 17, 2026
- EUDAMED b0af30ce-8971-4112-9d83-8bf8db3bcba7 61 fields · synced May 17, 2026
- FDA UDI 873b1ced-2942-47be-bd5c-bf0254c7ad15 36 fields · synced May 30, 2026
- EUDAMED 0f28e571-066c-4876-ba54-331453118454 61 fields · synced Jul 18, 2026