FDA.reportPublic FDA data

EPi-Ease Epicardial Access System

Primary DI
10840143910319
Brand
EPi-Ease Epicardial Access System
Company
ATRICURE, INC.
Model
EAS
Published
2024-07-18
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

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233959000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233959000EPi-Ease Epicardial Access Device (EAS)AtriCure, Inc.2024-02-13DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143910313PackageGS11In Commercial Distribution
50840143910317PackageGS110In Commercial Distribution
10840143910319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084014391031330840143910313
5084014391031750840143910317
1084014391031910840143910319

GMDN Terms#

Term, Definition table
TermDefinition
Epicardial catheter introduction setA collection of sterile, invasive, non-steerable devices intended to provide percutaneous sub-xiphoid access to enable introduction of a diagnostic catheter (not included) to the epicardial surface of the heart. It primarily includes: 1) a percutaneous introducer sleeve/tunneller with obturator, intended for initial introduction; 2) a retracting mechanism, intended to grab and separate the pericardium from the epicardial surface; 3) a needle, intended to puncture the pericardium; and 4) a haemostatic valve. This is a single-use device.

Regulatory Flags#

DUNS number
006133784
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

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Primary DI, Brand, Company table
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08498840011799VYGONVygon CorporationDYB2019-04-08
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08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
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07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
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00813502010558Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
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H965355110ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355120ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355130ENVINAVILYST MEDICAL, INC.DYB2017-08-07