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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
3cm Guided Coagulation System Kit FDA UDI
Model / Reference
CDK-1413 FDA UDI
Description
3cm Guided Coagulation System Kit FDA UDI

Identifiers

Catalog Number
A001280 FDA UDI
Primary DI / UDI-DI
10840143900327 FDA UDI
510(k) Number
K120857 FDA UDI
K142084 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

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 II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac radio-frequency ablation system generator.

Cleared under the same submission

K120857 also covers:

K142084 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA UDI 96971522-2406-46fb-a84e-cf7619dedc29 37 fields · synced May 29, 2026