Identity
- Trade Name
- EMBOL-X Intra-Aortic Filter with Duraflo Coating FDA UDI
- Generic Name
- Embolic protection filtering guidewire FDA UDI
- Device Name
- EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING FDA UDI
- Model / Reference
- EXXSD FDA UDI
- Description
- EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING FDA UDI
Identifiers
- Catalog Number
- EXXSD FDA UDI
- Primary DI / UDI-DI
- 00690103166330 FDA UDI
- 510(k) Number
- K062429 FDA UDI
- FDA Product Code
- DTM FDA UDI
- GMDN Term
- Embolic protection filtering guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4260 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
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
No
FDA UDI
Category: Embolic protection filtering guidewire
EMBOL-X Intra-Aortic Filter with Duraflo Coating by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062429 also covers:
- EMBOL-X Intra-Aortic Filter with Duraflo Coating — Edwards Lifesciences LLC
- EMBOL-X Intra-Aortic Filter with Duraflo Coating — Edwards Lifesciences LLC
- EMBOL-X Intra-Aortic Filter with Duraflo Coating — Edwards Lifesciences LLC
- EMBOL-X Intra-Aortic Filter with Duraflo Coating — 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 0f472e32-e338-46bb-85e2-ed2b52524d29 38 fields · synced Jun 8, 2026