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Quick-Cross Select Support Catheter
EUDAMEDFDA UDIClass III (EU MDR)
Ref 518-079Ref 518-091Ref 518-093Ref 518-077Ref 518-083Ref 518-081Ref 518-089
Identity
- Trade Name
- Quick-Cross Select Support Catheter EUDAMEDFDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Quick-Cross Select Support Catheter EUDAMED
- Model / Reference
- 518-079 EUDAMED518-091 EUDAMED518-093 EUDAMED518-077 EUDAMEDFDA UDI518-083 EUDAMED518-081 EUDAMED518-089 EUDAMED
Identifiers
- Catalog Number
- 518-077 FDA UDI
- Primary DI / UDI-DI
- 20813132021485 EUDAMED20813132021775 EUDAMED20813132021799 EUDAMED00813132021467 EUDAMEDFDA UDI20813132021461 EUDAMED20813132021690 EUDAMED20813132021676 EUDAMED20813132021751 EUDAMED
- Basic UDI-DI
- B-20813132021485 EUDAMEDB-20813132021775 EUDAMEDB-20813132021799 EUDAMEDB-00813132021467 EUDAMEDB-20813132021461 EUDAMEDB-20813132021690 EUDAMEDB-20813132021676 EUDAMEDB-20813132021751 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 Select 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-20813132021485 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-20813132021485 | 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 (9)
- EUDAMED d3d2f855-4595-4290-8eeb-0ea4c092cc6d 61 fields · synced Jul 31, 2026
- EUDAMED f949473e-27a2-448c-b5c0-314aa992c702 61 fields · synced May 17, 2026
- EUDAMED 218d9977-ed6c-427d-ab44-e33e0752e29f 61 fields · synced May 17, 2026
- EUDAMED 1283ca82-58db-4d2e-b938-354bea56f352 61 fields · synced May 18, 2026
- EUDAMED 5321c8f9-88ad-4a5e-a3d3-9f31ca2cf1f4 61 fields · synced May 18, 2026
- EUDAMED a4083eda-512d-48cd-bfa1-982753184807 61 fields · synced May 19, 2026
- EUDAMED 7109a481-b9d4-4225-9971-abc98010a850 61 fields · synced May 19, 2026
- EUDAMED 6123d6f0-fec3-4ac8-b369-153fd74dd36d 61 fields · synced May 19, 2026
- FDA UDI b5340c82-a393-48c1-8c16-dcd50c9a628f 36 fields · synced May 30, 2026