Identity
- Trade Name
- Edwards Lifesciences Peripheral Guidewire FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- PERIPHERAL GUIDEWIRE FDA UDI
- Model / Reference
- VEN210 FDA UDI
- Description
- PERIPHERAL GUIDEWIRE FDA UDI
Identifiers
- Catalog Number
- VEN210 FDA UDI
- Primary DI / UDI-DI
- 00690103146776 FDA UDI
- 510(k) Number
- K140208 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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: Cardiac/peripheral vascular guidewire, single-use
Edwards Lifesciences Peripheral Guidewire 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
K140208 also covers:
- EDWARDS LIFESCIENCES PERIPHERAL GUIDEWIRE — Edwards Lifesciences LLC
- Edwards Lifesciences Femoral Venous Cannula — Edwards Lifesciences LLC
- Edwards Lifesciences Femoral Venous Cannula — Edwards Lifesciences LLC
- Edwards Lifesciences Femoral Venous Cannula — Edwards Lifesciences LLC
- Edwards Lifesciences Femoral Venous Cannula — Edwards Lifesciences LLC
- Edwards Lifesciences Femoral Venous Cannula — Edwards Lifesciences LLC
- Edwards Lifesciences Femoral Venous Cannula — Edwards Lifesciences LLC
- Fem-Flex Femoral Arterial Cannula — Edwards Lifesciences LLC
- Fem-Flex Femoral Arterial Cannula — Edwards Lifesciences LLC
- Fem-Flex Femoral Arterial Cannula — Edwards Lifesciences LLC
- Fem-Flex Femoral Arterial Cannula — Edwards Lifesciences LLC
- Fem-Flex II Femoral Arterial Cannula — 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 |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 85b3b4c8-58e8-430a-b2f8-c96379bb365c 37 fields · synced Jun 8, 2026