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EPi-Sense Guided Coagulation System with VisiTrax

FDA UDI

Class II (US FDA UDI)

by Atricure, Inc.

Identity

Trade Name
EPi-Sense Guided Coagulation System with VisiTrax FDA UDI
Generic Name
Cardiac radio-frequency ablation system generator FDA UDI
Device Name
RF Coagulation Cable Kit FDA UDI
Model / Reference
CSK-2000 FDA UDI
Description
RF Coagulation Cable Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00818354015300 FDA UDI
FDA Product Code
OCL FDA UDI
GMDN Term
Cardiac radio-frequency ablation system generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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 radio-frequency ablation system generator

A comprehensive guide to the EPi-Sense Guided Coagulation System with VisiTrax, a medical device used for cardiac radio-frequency ablation. Learn about its features, benefits, and regulatory status.

Similar devices

Also classified as Cardiac radio-frequency ablation system generator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA UDI 64dbcea5-109b-4ee5-943c-2b53f3f40e8e 34 fields · synced Jun 19, 2026