FDA.reportPublic FDA data

NuVision ICE Catheter

Primary DI
00860005688104
Brand
NuVision ICE Catheter
Company
Biosense Webster Inc
Model
FG10593
Catalog number
FG10593
Device description
The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use.
Published
2021-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201775000NuVision ICE CatheterNuvera Medical, Inc.2021-03-05OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005688104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005688104008600056881048600056881040860005688104

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping/ultrasound imaging catheterA sterile, flexible, dual-purpose tube containing an arrangement of electrodes and ultrasonic imaging transducers at its distal tip, designed for: 1) electrophysiological diagnostic examinations such as electrophysiology (EP) mapping, sensing, and recording of cardiac structures; and 2) intracardiac ultrasound for visualization of the cardiac anatomy (inner surface), primarily to support the EP functions. It is introduced percutaneously through a compatible steerable guide catheter (not included) to enable manoeuvring within the cardiac anatomy. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damage
Special Storage Condition, Specify00Do not use if package is opened
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit

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
10846835026726Dual Energy Thermocool Smarttouch SF CatheterD134711D1347112026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterD134712D1347122026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterD134713D1347132026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterD134811D1348112026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterD134812D1348122026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterD134813D1348132026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterD134814D1348142026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterD134815D1348152026-07-09
10846835010121Sterile Interface CableD133701D1337012024-12-11
10846835016796TX eco EXT CableD135703D1357032023-10-04
10846835000184N/AC10MR10MSTKSC10MR10MSTKS2017-09-13
10846835000191N/AC5MHDTCMHSC5MHDTCMHS2017-09-13
10846835000207N/AC5MHNAVMHSC5MHNAVMHS2017-09-13
10846835000214N/AC5MHREFMHSC5MHREFMHS2017-09-13
10846835003666N/AC6MR10EPTRSC6MR10EPTRS2017-09-13
10846835003789Carto 3CB3410CTCB3410CT2016-09-16
10846835003796Carto 3CB3412CTCB3412CT2016-09-16
10846835003802Carto 3CB3434CTCB3434CT2016-09-16
10846835003826Carto 3CG2025CTCG2025CT2016-09-16
10846835003857Carto 3CR3425CTCR3425CT2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975345061102Disposable Intracardiac Echocardiography CatheterJiangsu Tingsn Technology Co., Ltd.OBJ2026-01-31
00884838112988Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838124929Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127098Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127111EPIQ 5 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127128EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
04056869957708AcuNav CRYSTAL G Ultrasound CatheterSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2025-11-21
05415067053190ViewFlex™IRVINE BIOMEDICAL, INC.OBJ2025-11-21
00845225003319Visions PV .014P RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
00845225003364Eagle Eye Platinum RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
00845225003371Eagle Eye Platinum ST RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
10841716103602ACIST Kodama® Coronary Imaging CatheterACIST MEDICAL SYSTEMS, INC.OBJ2025-08-14
10846835026559NUVISION NAV Ultrasound CatheterBiosense Webster IncOBJ2025-07-02
10846835026566NUVISION Ultrasound CatheterBiosense Webster IncOBJ2025-07-02
00884838126893EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126909Affiniti CVx Diagnostic Ultrasound System Philips Ultrasound LLCOBJ2025-06-23
00884838126923EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126930EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126947Affiniti CVx Diagnostic Ultrasound System Circular EditionPhilips Ultrasound LLCOBJ2025-06-23
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399239NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399178NES Reprocessed Visions PV .018 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-19
00845225012854ICE PIMPhilips Image Guided Therapy CorporationOBJ2025-03-24
07613327664096Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
07613327664102Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
07613327664119Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
57613327664091Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
57613327664107Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
04056869281483AcuNav Crystal Ultrasound CatheterSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2025-01-03