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Quick-Cross Extreme Support Catheter
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref 518-080
Identity
- Trade Name
- Quick-Cross Extreme Support Catheter EUDAMEDFDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Quick-Cross Extreme Support Catheter EUDAMED
- Model / Reference
- 518-080 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 518-080 FDA UDI
- Primary DI / UDI-DI
- 00813132021665 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132021665 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 — 135 Centimeter FDA UDILumen/Inner Diameter — 0.035 Inch FDA UDI
Quick-Cross Extreme Support Catheter by Spectranetics Corporation — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K092396 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K082561 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00813132021665 | 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 (3)
- EUDAMED d4d83723-c87b-45ca-93e0-35746f6b143f 61 fields · synced Jun 20, 2026
- FDA UDI 23b56d82-fad2-49a6-bf7c-817213694719 36 fields · synced May 30, 2026
- FDA 510(k) K092396 1 fields · synced May 18, 2026