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EPi-Sense Guided Coagulation System with VisiTrax
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- EPi-Sense Guided Coagulation System with VisiTrax FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system generator FDA UDI
- Device Name
- 3 cm Guided Coagulation System Kit FDA UDI
- Model / Reference
- CDK-1413 FDA UDI
- Description
- 3 cm Guided Coagulation System Kit FDA UDI
Identifiers
- Catalog Number
- CDK-1413-3 FDA UDI
- Primary DI / UDI-DI
- 10840143904554 FDA UDI
- PMA Number
- P200002 FDA UDI
- FDA Product Code
- OCM FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation system generator 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 3 Centimeter FDA UDI
Category: Cardiac radio-frequency ablation system generator
EPi-Sense Guided Coagulation System with VisiTrax by Atricure, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120857 also covers:
K142084 also covers:
P200002 also covers:
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 |
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Manufacturer
- Manufacturer
- Atricure, Inc.
Sources (1)
- FDA UDI 1239ebde-ff20-4167-a932-e28f30532c9b 37 fields · synced Jun 6, 2026