FDA.reportPublic FDA data

EPi-Sense Guided Coagulation System with VisiTrax

Primary DI
10840143904554
Brand
EPi-Sense Guided Coagulation System with VisiTrax
Company
ATRICURE, INC.
Model
CDK-1413
Catalog number
CDK-1413-3
Device description
3 cm Guided Coagulation System Kit
Published
2021-05-24
Public version status
Update
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
OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac TissueGeneral, Plastic Surgery2
OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial FibrillationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120857000
K142084000
P200002000
P200002004
P200002005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120857000EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAXNcontact Surgical, Inc.2012-11-13OCL
K142084000EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAXNcontact Surgical, Inc.2014-10-28OCL
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143903827PackageGS11In Commercial Distribution
50840143903364PackageGS124In Commercial Distribution
10840143904554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084014390382730840143903827
5084014390336450840143903364
1084014390455410840143904554

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac radio-frequency ablation system generatorA mains electricity (AC-powered) 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-349-2342xxx@xxx.xxx

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
10840143909375EPi-Sense Guided Coagulation SystemATRICURE, 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
00199150027521Cardioblate™MEDTRONIC, INC.OCL2026-01-16
00199150027538Cardioblate™MEDTRONIC, INC.OCL2026-01-16
00763000841607Cardioblate™ Gemini™-sMEDTRONIC, INC.OCL2025-05-18
10884521851566ValleylabCovidien LPOCL2025-05-12
10840143911767AtriCure Isolator Synergy EnCapture ClampATRICURE, INC.OCL2025-03-14
30840143911761AtriCure Isolator Synergy EnCapture ClampATRICURE, INC.OCL2025-03-14
10884521829527ValleylabCovidien LPOCL2024-10-03
10884521829534ValleylabCovidien LPOCL2024-10-03
00763000841591Cardioblate™ Gemini™-sMEDTRONIC, INC.OCL2024-04-28
30840143904473Multifunctional Ablation GeneratorATRICURE, INC.OCM2023-02-21
10840143900044Multifunctional Ablation GeneratorATRICURE, INC.OCM2023-02-21
10840143905995AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
10840143905834AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
30840143904817AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
10840143905193AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
30840143904114AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
10840143905209AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
10840143905520AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
10840143901485Coagulation RF cableATRICURE, INC.OCM2022-09-23