FDA.reportPublic FDA data

Subtle Cannula with Guide

Primary DI
10840143900280
Brand
Subtle Cannula with Guide
Company
ATRICURE, INC.
Model
CSK-6130
Device description
30cm Cannula with Guide
Published
2021-01-08
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
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120857000
K142084000

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143900291PackageGS11In Commercial Distribution
50840143900219PackageGS150In Commercial Distribution
00818354015379PreviousGS10
10840143900280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084014390029130840143900291
5084014390021950840143900219
00818354015379008183540153798183540153790818354015379
1084014390028010840143900280

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840143919350AtriClip® Selection GuideCGG100A000349-162026-10-09
10840143912788cryoICE®CRYO2A0015602026-09-29
10840143912795cryoICE®CRYO3A0015612026-09-29
10840143912801cryoICE® cryoFORM™CRYOFA0015622026-09-29
10840143912832Cannula with GuideCSK-6131CSK-6131-32026-05-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4531121L0PEAK MEDICALPeak Medical Distribution Inc.GEA2026-10-28
G4531121M0PEAK MEDICALPeak Medical Distribution Inc.GEA2026-10-28
G4531121S0PEAK MEDICALPeak Medical Distribution Inc.GEA2026-10-28
00810130456901Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456918Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456925Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456932Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456949Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456956Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456963Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456970Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456987Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456994Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457007Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457014Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457021Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457038Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457045Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457052Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457069Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457076Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457083Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457106Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457113Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457120Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457137Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457144Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457168Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457175Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457182Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23