Identity
- Trade Name
- SSPC Delivery Catheter EUDAMEDSSPC4 Delivery Catheter FDA UDI
- Generic Name
- Pacing/defibrillation lead delivery catheter FDA UDI
- Device Name
- SSPC Delivery Catheter EUDAMEDCatheter and Dilator FDA UDI
- Model / Reference
- 9184 EUDAMEDFDA UDI
- Description
- Catheter and Dilator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810024670048 EUDAMED00810024671847 FDA UDI
- Basic UDI-DI
- B-00810024670048 EUDAMED
- 510(k) Number
- K190475 FDA UDI
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
- GMDN Term
- Pacing/defibrillation lead delivery catheter FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Catheter Length — 40 Centimeter FDA UDI
SSPC Delivery Catheter by CenterPoint Systems LLC — Class III — 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-00810024670048 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- CenterPoint Systems LLC
- EUDAMED SRN
- US-MF-000009054
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED c2fe72ef-546a-4188-9140-02a73e473373 61 fields · synced Jul 31, 2026
- FDA UDI fb923865-731a-4bea-9fdf-bd655710c70e 37 fields · synced May 30, 2026