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Quick-Cross Capture Guidewire Retriever
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 519-106
Identity
- Trade Name
- Quick-Cross Capture Guidewire Retriever EUDAMEDFDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Quick-Cross Capture Guidewire Retriever EUDAMED
- Model / Reference
- 519-106 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 519-106 FDA UDI
- Primary DI / UDI-DI
- 00813132020996 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132020996 EUDAMED
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C019002 EMBOLECTOMY CATHETERS EUDAMED
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class IIa 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
- Lumen/Inner Diameter — 0.035 Inch FDA UDILength — 110 Centimeter FDA UDI
Quick-Cross Capture Guidewire Retriever by Spectranetics Corporation — Class IIa — 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-00813132020996 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 543d5af2-246a-45b4-90aa-fdf06109bcbf 61 fields · synced Jul 11, 2026
- FDA UDI 19f735b4-3b76-4312-b216-8cab0a923b3f 36 fields · synced May 30, 2026