Identity
- Trade Name
- EVOQUE FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Edwards EVOQUE Dilator Kit (24, 28, 33 Fr dilators) FDA UDI
- Model / Reference
- 9850DKUS FDA UDI
- Description
- Edwards EVOQUE Dilator Kit (24, 28, 33 Fr dilators) FDA UDI
Identifiers
- Catalog Number
- 9850DKUS FDA UDI
- Primary DI / UDI-DI
- 00690103217506 FDA UDI
- PMA Number
- P230013 FDA UDI
- FDA Product Code
- NPW FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class III 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
Yes
FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Evoque by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P230013 also covers:
- EVOQUE — Edwards Lifesciences LLC
- EVOQUE — Edwards Lifesciences LLC
- EVOQUE — Edwards Lifesciences LLC
- EVOQUE — Edwards Lifesciences LLC
- EVOQUE — Edwards Lifesciences LLC
- EVOQUE — Edwards Lifesciences LLC
- EVOQUE — Edwards Lifesciences LLC
- EVOQUE — Edwards Lifesciences LLC
- Edwards EVOQUE Loading System — Edwards Lifesciences LLC
- Edwards EVOQUE Loading System — Edwards Lifesciences LLC
- Edwards EVOQUE Stabilizer — Edwards Lifesciences LLC
- Edwards EVOQUE Valve — 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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 6824b62d-cf89-481c-ae24-4c6390f3d5ef 36 fields · synced Jun 8, 2026