FDA.reportPublic FDA data

AtriClip® Flex-V® LAA Exclusion System

Primary DI
30840143912003
Brand
AtriClip® Flex-V® LAA Exclusion System
Company
ATRICURE, INC.
Model
ACHV45
Catalog number
A001019-4
Device description
LAA Exclusion System, ACHV45
Published
2024-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
30840143912003PackageGS11In Commercial Distribution
50840143912007PackageGS112In Commercial Distribution
10840143906640PreviousGS10
10840143912009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084014391200330840143912003
5084014391200750840143912007
1084014390664010840143906640
1084014391200910840143912009

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-449-2342SEhlert@atricure.com

Regulatory Flags#

DUNS number
006133784
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
10840143919602AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-10
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