FDA.reportPublic FDA data

Carto 3

Primary DI
10846835009712
Brand
Carto 3
Company
Biosense Webster Inc
Model
D134401
Catalog number
D134401
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113213000LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2Biosense Webster, Inc.2011-12-05DRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846835009712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084683500971210846835009712

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Do not use if package is opened
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Keep Dry | Keep out of direct sunlight
Special Storage Condition, Specify00Keep out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)729-9010RA-BWIUS-Complaints@its.jnj.com

Regulatory Flags#

DUNS number
020163218
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10846835008883CARTO 3D128622D1286222016-09-16
10846835008838SOUNDSTAR10438577104385772016-09-16
10846835009798THERMOCOOL SMARTTOUCH SFD134703D1347032016-11-11
10846835010121Sterile Interface CableD133701D1337012024-12-11
10846835016796TX eco EXT CableD135703D1357032023-10-04
10846835025811OPTRELL Mapping Catheter with TRUEref TechnologyD142902D1429022023-10-04
10846835025828OPTRELL Mapping Catheter with TRUEref TechnologyD142901D1429012023-10-04
10846835017427TX eco CableD140102D1401022023-07-21
10846835016710QDOT MICROD139501D1395012023-07-07
10846835016727QDOT MICROD139502D1395022023-07-07
10846835016734QDOT MICROD139503D1395032023-07-07
10846835016741QDOT MICROD139504D1395042023-07-07
10846835016758QDOT MICROD139505D1395052023-07-07
10846835017045QDOT MICROD139401D1394012023-07-07
10846835017076QDOT MICROD139402D1394022023-07-07
10846835017106QDOT MICROD139403D1394032023-07-07
10846835021110OCTARAY Mapping CatheterD160902D1609022021-10-14
10846835021127OCTARAY Mapping CatheterD160903D1609032021-10-14
10846835021134OCTARAY Mapping CatheterD160906D1609062021-10-14
10846835021141OCTARAY Mapping CatheterD160901D1609012021-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818087022873MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087022880MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087022897MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023054MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023061MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00854277008135Vision-MR® Diagnostic CatheterImricor Medical Systems, Inc.DRF2026-05-06
04260192830601EasyMap MAP M (70mm)MedFact Engineering GmbHDRF2026-01-30
04260192832124EasyMap MAP L (80mm)MedFact Engineering GmbHDRF2026-01-30
04260192832131EasyMap MAP XL (90mm)MedFact Engineering GmbHDRF2026-01-30
24255650100406EasyConnect MAP CableMedFact Engineering GmbHDRF2026-01-30
00850012226000Axis Patient PatchesCardionxt IncDRF2025-12-10
00850012226154Multilink CS CatheterCardionxt IncDRF2025-12-10
06952450942581EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
06952450942604EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
05414734202701Livewire™ST. JUDE MEDICAL, INC.DRF2023-10-31
00763000445720NAMEDTRONIC, INC.DRF2023-03-18
10801902198379ARROWTELEFLEX INCORPORATEDDRF2022-11-17
10801902198348ARROWTELEFLEX INCORPORATEDDRF2022-10-28
10801902198256ARROWTELEFLEX INCORPORATEDDRF2022-10-21
10801902198317ARROWTELEFLEX INCORPORATEDDRF2022-10-17
10846835018080nGEN GeneratorBiosense Webster IncDRF2022-08-18
10801902211481ARROWTELEFLEX INCORPORATEDDRF2022-06-13
10801902211504ARROWTELEFLEX INCORPORATEDDRF2022-06-13
10801902198300ARROWTELEFLEX INCORPORATEDDRF2022-05-16
10801902198409ARROWTELEFLEX INCORPORATEDDRF2022-05-16
10801902198393ARROWTELEFLEX INCORPORATEDDRF2022-05-11
10801902004533ARROWTELEFLEX INCORPORATEDDRF2018-10-25
20801902004301ARROWTELEFLEX INCORPORATEDDRF2018-10-25
00643169778184NAMEDTRONIC, INC.DRF2016-11-04