Identity
- Trade Name
- Fogarty FDA UDI
- Generic Name
- Thrombectomy balloon catheter FDA UDI
- Device Name
- Fogarty Embolectomy Catheter FDA UDI
- Model / Reference
- 120805FP FDA UDI
- Description
- Fogarty Embolectomy Catheter FDA UDI
Identifiers
- Catalog Number
- 120805FP FDA UDI
- Primary DI / UDI-DI
- 00690103205220 FDA UDI
- 510(k) Number
- K193379 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
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
Category: Thrombectomy balloon catheter
Fogarty by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy balloon catheter.
- LMI ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INC · Class II
- Syntel Silicone Embolectomy Catheter — LeMaitre Vascular, Inc. · Class II
- LeMaitre Embolectomy Catheter — LeMaitre Vascular, Inc. · Class II
- LeMaitre Embolectomy Catheter — LeMaitre Vascular, Inc. · Class II
- Biosensors Embolectomy Catheter — BIOPTIMAL INTERNATIONAL PTE. LTD. · Class II
- Syntel Embolectomy Catheter (Regular Tip) — APPLIED MEDICAL RESOURCES CORP. · Class II
- LeMaitre Embolectomy Catheter — LeMaitre Vascular, Inc. · Class II
- LMI ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INC · Class II
Cleared under the same submission
K193379 also covers:
- FOGARTY — Edwards Lifesciences LLC
- FOGARTY — Edwards Lifesciences LLC
- FOGARTY — Edwards Lifesciences LLC
- FOGARTY — Edwards Lifesciences LLC
- FOGARTY — Edwards Lifesciences LLC
- FOGARTY — Edwards Lifesciences LLC
- Fogarty — Edwards Lifesciences LLC
- Fogarty — Edwards Lifesciences LLC
- Fogarty — Edwards Lifesciences LLC
- Fogarty — Edwards Lifesciences LLC
- Fogarty — Edwards Lifesciences LLC
- Fogarty — Edwards Lifesciences LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI a3eca90d-28b8-44ff-90df-448d0ce63ed1 38 fields · synced Jun 8, 2026