FDA.reportPublic FDA data

AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion System

Primary DI
10840143919602
Brand
AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion System
Company
ATRICURE, INC.
Model
ACH235
Catalog number
A000916
Device description
LAA Exclusion System, ACH235
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZXLeft Atrial Appendage Clip, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZXLeft Atrial Appendage Clip, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233407000AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)AtriCure, Inc.2023-11-02PZX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143919606PackageGS11In Commercial Distribution
50840143919600PackageGS112In Commercial Distribution
10840143913365PreviousGS10
10840143919602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084014391960630840143919606
5084014391960050840143919600
1084014391336510840143913365
1084014391960210840143919602

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Fahrenheit140 Degrees Fahrenheit
Special Storage Condition, Specify00Store in a cool, dry place

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
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
10840143907845Subtle Cannula with Guide CSK-6130A001286-32026-04-23
10840143907852Cannula with GuideCSK-6131CSK-61312026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840143913440AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913457AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913464AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913471AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913488AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913495AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913501AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913518AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913525AtriClip PROV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913532AtriClip PROV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913549AtriClip PROV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913556AtriClip PROV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143914270AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143914287AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143914294AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143914300AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913327AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-20
10840143913334AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-20
10840143913341AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-20
10840143913358AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-20
10840143913402AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-13
10840143913419AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-13
10840143913426AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-13
10840143913433AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-13
10840143919619AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-10
10840143919626AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-10
10840143919633AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-10
10840143913365AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-03-25
10840143913372AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-03-25
10840143913389AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-03-25