FDA.reportPublic FDA data

Subtle Cannula with Guide

Primary DI
10840143907845
Brand
Subtle Cannula with Guide
Company
ATRICURE, INC.
Model
CSK-6130
Catalog number
A001286-3
Device description
30 cm Cannula with Guide
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

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143907849PackageGS11In Commercial Distribution
50840143907843PackageGS150In Commercial Distribution
10840143907845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084014390784930840143907849
5084014390784350840143907843
1084014390784510840143907845

GMDN Terms#

Term, Definition table
TermDefinition
Pleuroscopic/mediastinoscopic access cannula, reusableA rigid, single-lumen, surgical instrument intended to be percutaneously inserted through the chest to provide access to the pleural and/or mediastinal cavity to facilitate the introduction of surgical instruments as part of a minimally-invasive procedure; it is not intended for pericardial access. It provides an entry between adjacent ribs and once in place is intended to remain in position for the duration of the procedure. It may include a trocar with a sharp or blunt tip intended to assist introduction; devices with the trocar included it may be referred to as a trocar or trocar assembly. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter

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
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
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
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
10840143913761Isolator Synergy™ ATRICURE, INC.OCM2026-05-12
10840143907807EPi-Sense Guided Coagulation SystemATRICURE, 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