Identity
- Trade Name
- Wirion Retrieval Catheter FDA UDI
- Generic Name
- Embolic protection filtering guidewire FDA UDI
- Device Name
- The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 72900155120105 Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed. FDA UDI
- Model / Reference
- P4-9-0703 FDA UDI
- Description
- The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 72900155120105 Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed. FDA UDI
Identifiers
- Catalog Number
- P4-9-0703 FDA UDI
- Primary DI / UDI-DI
- 72900155120301 FDA UDI
- 510(k) Number
- K143570 FDA UDI
- FDA Product Code
- NTE FDA UDI
- GMDN Term
- Embolic protection filtering guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
No
FDA UDI
Wirion Retrieval Catheter by Gardia Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Gardia Medical
Sources (1)
- FDA UDI 69d2c814-b1bc-4c49-8701-a3d5be9f5601 37 fields · synced May 30, 2026