FDA.reportPublic FDA data

EnSite™

Primary DI
05415067057969
Brand
EnSite™
Company
ST. JUDE MEDICAL, INC.
Model
ENSITE-AG-01
Catalog number
ENSITE-AG-01
Device description
X EP System EnSite™ AI Geo Software License
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K261729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261729000EnSite™ X EP SystemAbbott Medical2026-09-17DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067057969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067057969054150670579695415067057969

Contacts#

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

Regulatory Flags#

DUNS number
149818952
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067057341Navitor™NVRO-35NVRO-352026-11-05
05415067057365Navitor™NVRO-29NVRO-292026-11-05
05415067057389Navitor™NVRO-27NVRO-272026-11-05
05415067057402Navitor™NVRO-25NVRO-252026-11-05
05415067057426Navitor™NVRO-23NVRO-232026-11-05
05415067057242Amplatzer™9-APVL-1439-APVL-1432026-11-02
05415067057259Amplatzer™9-APVL-0849-APVL-0842026-11-02
05415067057266Amplatzer™9-APVL-1239-APVL-1232026-11-02
05415067057273Amplatzer™9-APVL-0639-APVL-0632026-11-02
05415067057280Amplatzer™9-APVL-1059-APVL-1052026-11-02
05415067057297Amplatzer™9-APVL-0429-APVL-0422026-11-02
05415067057303Amplatzer™9-APVL-1039-APVL-1032026-11-02
05415067057310Amplatzer™9-APVL-1259-APVL-1252026-11-02
05415067057327Amplatzer™9-APVL-1459-APVL-1452026-11-02
05414734008242Fast-Cath™4061044061042015-03-20
05414734008266Fast-Cath™4061204061202015-03-20
05414734008280Fast-Cath™4061284061282015-03-20
05414734008303Fast-Cath™4061404061402015-03-12
05414734008327Fast-Cath™4061624061622015-02-28
05414734008341Maximum™4062504062502015-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05061136120005HeartKey Edge ECGB-SECUR LIMITEDDQK2026-11-05
05061136120012HeartKey RhythmB-SECUR LIMITEDDQK2026-11-05
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-10-28
08800159500060S-Patch CardioAIWellysis Corp.DQK2026-10-27
00860009793538STAR ArtemisRhythm AI Inc.DQK2026-10-26
00195278840202MACGe Medical Systems Information Technologies, Inc.DQK2026-10-13
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQK2026-10-04
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-09-20
00885403523512HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403523536HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403533764Smart Pressure ControllerBecton, Dickinson And CompanyDQK2026-09-18
00885403533771Smart Pressure Controller Accessory KitBecton, Dickinson And CompanyDQK2026-09-18
00199150062911N/AMEDTRONIC, INC.DQK2026-09-04
00198953213063ComboLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213087CardioLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
00885403523437HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21