Identity
- Trade Name
- Boosting Catheter EUDAMEDFDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Boosting Catheter EUDAMEDSupport Catheter, .052" ID x 150cm FDA UDI
- Model / Reference
- BC52-150 EUDAMEDFDA UDI
- Description
- Support Catheter, .052" ID x 150cm FDA UDI
Identifiers
- Catalog Number
- BC52-150 FDA UDI
- Primary DI / UDI-DI
- 00853892004058 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00853892004058 EUDAMED
- 510(k) Number
- K160561 FDA UDI
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C0104010202 CARDIAC 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
- France 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
- Lumen/Inner Diameter — 0.052 Inch FDA UDILength — 150 Centimeter FDA UDI
Boosting Catheter by QXMedical, LLC — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K160561 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00853892004058 | Class III | Active |
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Manufacturer
- Manufacturer
- QXMedical, LLC
- EUDAMED SRN
- US-MF-000008536
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED e242a804-b4a9-4be4-bd26-1d930bf92ffb 61 fields · synced Jul 28, 2026
- FDA UDI 563ea901-9b32-4a5d-bf78-cb8529cf94e3 37 fields · synced May 30, 2026
- FDA 510(k) K160561 1 fields · synced May 18, 2026