FDA.reportPublic FDA data

Isolator Synergy™

Primary DI
10840143913761
Brand
Isolator Synergy™
Company
ATRICURE, INC.
Model
OSL2
Catalog number
A000432-12
Device description
Isolator Synergy Clamp, Short Jaw, Left Curve
Published
2026-05-12
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
P100046019

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100046019ATRICURE SYNERGY ABLATION SYSTEMAtriCure, Inc.2011-12-14OCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143909218PackageGS11In Commercial Distribution
50840143909212PackageGS16In Commercial Distribution
10840143913761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084014390921830840143909218
5084014390921250840143909212
1084014391376110840143913761

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.

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10840143913525AtriClip PROV® LAA Exclusion SystemPROV35A000971-42026-04-28
10840143913532AtriClip PROV® LAA Exclusion SystemPROV40A000972-42026-04-28
10840143913549AtriClip PROV® LAA Exclusion SystemPROV45A000973-42026-04-28
10840143913556AtriClip PROV® LAA Exclusion SystemPROV50A000974-42026-04-28
10840143914270AtriClip® FlexV® LAA Exclusion SystemACHV35A001017-42026-04-28
10840143914287AtriClip® FlexV® LAA Exclusion SystemACHV40A001018-42026-04-28
10840143914294AtriClip® FlexV® LAA Exclusion SystemACHV45A001019-42026-04-28
10840143914300AtriClip® FlexV® LAA Exclusion SystemACHV50A001020-42026-04-28
10840143907807EPi-Sense Guided Coagulation SystemCDK-1413CDK-1413-32026-04-23
10840143907845Subtle Cannula with Guide CSK-6130A001286-32026-04-23
10840143907852Cannula with GuideCSK-6131CSK-61312026-04-23
10840143909375EPi-Sense Guided Coagulation SystemCSK-2000csk-2000-22026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
30840143902141Synergy™ Ablation SystemATRICURE, INC.OCM2021-01-08