FDA.reportPublic FDA data

EPi-Sense Guided Coagulation System

Primary DI
10840143909375
Brand
EPi-Sense Guided Coagulation System
Company
ATRICURE, INC.
Model
CSK-2000
Catalog number
csk-2000-2
Device description
Coagulation RF Cable
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial FibrillationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200002000
P200002004
P200002005
P200002007
P200002010

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200002000EPi-Sense Guided Coagulation SystemAtriCure, Inc.2021-04-28OCM
P200002004EPi-Sense Guided Coagulation SystemAtriCure, Inc.2021-04-28OCM
P200002005EPi-Sense Guided Coagulation SystemAtriCure, Inc.2021-04-28OCM
P200002007EPi-Sense Guided Coagulation SystemAtriCure, Inc.2021-04-28OCM
P200002010EPi-Sense Guided Coagulation SystemAtriCure, Inc.2021-04-28OCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143909379PackageGS11In Commercial Distribution
50840143909373PackageGS1108In Commercial Distribution
10840143904530PreviousGS10
10840143909375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084014390937930840143909379
5084014390937350840143909373
1084014390453010840143904530
1084014390937510840143909375

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac radio-frequency ablation system generatorAn electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Fahrenheit131 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
866-449-2342SEhlert@atricure.com

Regulatory Flags#

DUNS number
006133784
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840143902666cryoICE® SystemA001150A001150-12026-05-27
10840143902673cryoICE® SystemA001150A001150-22026-05-27
10840143902680cryoICE® SystemA001150A001150-32026-05-27
10840143902697cryoICE® SystemA001150A001150-42026-05-27
10840143902703cryoICE® SystemA001150A001150-52026-05-27
10840143902710cryoICE® SystemA001150A001150-62026-05-27
10840143902727cryoICE® SystemA001150A001150-72026-05-27
10840143902734cryoICE® SystemA001150A001150-82026-05-27
30840143904343cryoICE® SystemCMF1A0013592026-05-27
30840143912164AtriCure® cryoICE® BOXACM1A000896-52026-05-27
30840143913703Multifunctional Ablation GeneratorMAGA0013722026-05-27
10840143913761Isolator Synergy™ OSL2A000432-122026-05-12
10840143913440AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO135A0008242026-04-28
10840143913457AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO140A0008252026-04-28
10840143913464AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO145A0008262026-04-28
10840143913471AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO150A0008272026-04-28
10840143913488AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO235A0009652026-04-28
10840143913495AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO240A0009662026-04-28
10840143913501AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO245A0009672026-04-28
10840143913518AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO250A000968 2026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30840143913703Multifunctional Ablation GeneratorATRICURE, INC.OCM2026-05-27
10840143913761Isolator Synergy™ ATRICURE, INC.OCM2026-05-12
10840143907807EPi-Sense Guided Coagulation SystemATRICURE, INC.OCM2026-04-23
10840143907845Subtle Cannula with Guide ATRICURE, INC.OCM2026-04-23
10840143907852Cannula with GuideATRICURE, INC.OCM2026-04-23
10840143909382EPi-Sense ST Guided Coagulation SystemATRICURE, INC.OCM2026-04-23
10840143913273EPi-Sense STATRICURE, INC.OCM2026-04-23
10840143913884EPi-Sense STATRICURE, INC.OCM2026-04-23
30840143902950Isolator Surgical Ablation SystemATRICURE, INC.OCM2026-02-06
10840143901553Isolator Surgical Ablation SystemATRICURE, INC.OCM2026-02-06
30840143904473Multifunctional Ablation GeneratorATRICURE, INC.OCM2023-02-21
10840143900044Multifunctional Ablation GeneratorATRICURE, INC.OCM2023-02-21
10840143901485Coagulation RF cableATRICURE, INC.OCM2022-09-23
10840143904585EPi-Sense ST Coagulation Device ATRICURE, INC.OCM2022-09-23
30840143901663Coagulation RF cableATRICURE, INC.OCM2022-09-23
10840143901607Cannula with GuideATRICURE, INC.OCM2022-09-23
30840143901656EPi-Sense ST Coagulation Device ATRICURE, INC.OCM2022-09-23
10840143904530Coagulation RF CableATRICURE, INC.OCM2021-05-24
10840143904547Subtle Cannula with Guide ATRICURE, INC.OCM2021-05-24
10840143904578nContact RF GeneratorATRICURE, INC.OCM2021-05-24
30840143903803Coagulation RF CableATRICURE, INC.OCM2021-05-24
30840143903810Subtle Cannula with Guide ATRICURE, INC.OCM2021-05-24
10840143904554EPi-Sense Guided Coagulation System with VisiTraxATRICURE, INC.OCM2021-05-24
10840143904561nContact RF GeneratorATRICURE, INC.OCM2021-05-24
30840143902134nContact RF GeneratorATRICURE, INC.OCM2021-05-24
10840143901584Synergy™ Ablation SystemATRICURE, INC.OCM2021-01-11
30840143903018Synergy™ Ablation SystemATRICURE, INC.OCM2021-01-11
10840143904028Ablation Sensing Unit ATRICURE, INC.OCM2021-01-11
10840143902109Synergy™ Ablation SystemATRICURE, INC.OCM2021-01-08
10840143902192Synergy™ Ablation SystemATRICURE, INC.OCM2021-01-08