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
- 518-037 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 518-037 FDA UDI
- Primary DI / UDI-DI
- 00813132029371 EUDAMEDFDA UDI
- Basic UDI-DI
- 081313202BM384MD EUDAMED
- 510(k) Number
- K033678 FDA UDI
- 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 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
- Length — 135 Centimeter FDA UDILumen/Inner Diameter — 0.035 Inch FDA UDI
Quick-Cross support catheter by Spectranetics Corporation — Class IIa — 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 | 081313202BM384MD | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 081313202BM384MD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Image Guided Therapy Corporation
- EUDAMED SRN
- US-MF-000018632
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED d10c9973-e9f3-4ea5-b6d0-564cde9778db 61 fields · synced Jul 11, 2026
- EUDAMED 7aae08fb-3afa-4e20-ac91-7fca2edbca51 61 fields · synced May 19, 2026
- FDA UDI 3c13cbe8-7c2c-4323-ab69-65e9a3b2fcf3 37 fields · synced May 29, 2026