Identity
- Trade Name
- D*Clot® HD Rotational Thrombectomy System FDA UDI
- Generic Name
- Thrombectomy rotational catheter FDA UDI
- Device Name
- The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts FDA UDI
- Model / Reference
- D*Clot® HD 6Fx40CM FDA UDI
- Description
- The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts FDA UDI
Identifiers
- Catalog Number
- T10106040 FDA UDI
- Primary DI / UDI-DI
- 15711055004326 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- Thrombectomy rotational catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Dimensions & Sizes
- Size
- Catheter Gauge — 6F French FDA UDICatheter Length — 40 Centimeter FDA UDI
D*Clot® HD Rotational Thrombectomy System by Mermaid Medical A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mermaid Medical A/S
Sources (1)
- FDA UDI 7024f4df-7925-437a-af36-975da7b95e14 38 fields · synced Jun 1, 2026