Identity
- Trade Name
- FOGARTY FDA UDI
- Generic Name
- Thrombectomy balloon catheter FDA UDI
- Device Name
- FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 80CM FDA UDI
- Model / Reference
- 12A0804F FDA UDI
- Description
- FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 80CM FDA UDI
Identifiers
- Catalog Number
- 12A0804F FDA UDI
- Primary DI / UDI-DI
- 00690103043402 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- Thrombectomy balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thrombectomy balloon catheter
Fogarty by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI eaff30dc-dda0-458f-8de4-777f73a5e86f 37 fields · synced Jun 8, 2026