FDA.reportPublic FDA data

EnSite™

Primary DI
05415067047861
Brand
EnSite™
Company
ST. JUDE MEDICAL, INC.
Model
ENSITE-TFM-03
Catalog number
ENSITE-TFM-03
Device description
X EP System TactiFlex Ablation Cath, SE Software Upgrade
Published
2023-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, diagnostic, programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231415000
K242016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231415000EnSite™ X EP SystemABBOTT MEDICAL2023-08-10DQK
K242016000EnSite™ X EP SystemABBOTT MEDICAL2024-08-09DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067047861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067047861054150670478615415067047861

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system application softwareAn individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. It is a basic set of application programs and routines used for cardiac mapping computer-controlled imaging which can be upgraded to correct programming errors or to add new system capabilities. An application program package is typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067052742Epic™ESP300-23ESP300-232026-07-08
05415067052759Epic™EELT-23AEELT-23A2026-07-08
05415067052766Epic™EELT-31MEELT-31M2026-07-08
05415067052780Epic™EELT-27MEELT-27M2026-07-08
05415067052797Epic™ESP300-25ESP300-252026-07-08
05415067052803Epic™ESP300-19ESP300-192026-07-08
05415067052810Epic™EELT-19AEELT-19A2026-07-08
05415067052827Epic™EELT-29MEELT-29M2026-07-08
05415067052834Epic™EELT-27AEELT-27A2026-07-08
05415067052858Epic™EELT-25AEELT-25A2026-07-08
05415067052865Epic™EELT-21AEELT-21A2026-07-08
05415067052872Epic™EELT-33MEELT-33M2026-07-08
05415067052889Epic™ESP300-27ESP300-272026-07-08
05415067052896Epic™EELT-25MEELT-25M2026-07-08
05415067052902Epic™ESP300-21ESP300-212026-07-08
05415067052964Epic™ESP1000-AESP1000-A2026-07-08
05415067052971Epic™EELT-1000MEELT-1000M2026-07-08
05415067052988Epic™EELT-1000AEELT-1000A2026-07-08
05415067054197NAEELT-19A-SEELT-19A-S2026-07-08
05415067054203NAEELT-29A-SEELT-29A-S2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDQK2025-12-09
17540279200027CardioSTATIcentia Inc.DQK2025-12-08
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
27540279250029CardioSTATIcentia Inc.DQK2024-12-18
27540279250074CardioSTATIcentia Inc.DQK2024-12-18
27540279250142CardioSTATIcentia Inc.DQK2024-12-18
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
17540279200140CardioSTATIcentia Inc.DQK2024-03-26
00191506033002AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033125AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033194AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033200AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
08800069700178AT-PatchATsens Co., Ltd.DQK2022-12-23
00195278276070MACGe Medical Systems Information Technologies, Inc.DQK2022-11-09
B273CEA0Cardiologs PlatformCARDIOLOGS TECHNOLOGIESDQK2021-12-08
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982876MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29