FDA.reportPublic FDA data

Foresight ICE™ Catheter

Primary DI
00628055603016
Brand
Foresight ICE™ Catheter
Company
Conavi Medical Inc
Model
TA-01-0001
Device description
Imaging catheter
Published
2020-09-11
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162789000Foresight Intracardiac Echocardiology (ICE) SystemConavi Medical, Inc.2017-03-28DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01628055603015PackageGS11In Commercial Distribution
05628055603011PackageGS15In Commercial Distribution
10628055603013PackageGS110In Commercial Distribution
00628055603016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01628055603015016280556030151628055603015
05628055603011056280556030115628055603011
1062805560301310628055603013
00628055603016006280556030166280556030160628055603016

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac ultrasound imaging catheter, steerable, single-useA steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart; it is not intended for peripheral vascular or coronary artery insertion/imaging. It is introduced percutaneously, and includes controls to allow it to be manoeuvred (steerable). It is connected to a compatible ultrasound system for transmission and display of the images. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
416-483-0100customerservice@conavi.com

Regulatory Flags#

DUNS number
200125243
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055603115Novasight Hybrid™ CatheterTA-06-00012023-04-17
00628055603054Novasight Hybrid™ CatheterTA-06-00012020-09-09
00628055603092Novasight Hybrid™ PIMTA-07-00022022-10-25
01628055603015Foresight ICE™ CatheterTA-01-00012020-09-11
00628055603023Foresight ICE™ Catheter Accessories PackageSA-01-00152020-09-11
00628055603030Foresight ICE™ Hummingbird ConsoleTA-03-00012020-09-11
00628055603047Foresight ICE™ PIMTA-02-00012020-09-11
00628055603061Novasight Hybrid™ Catheter Accessories PackageSA-10-00222020-09-11
00628055603078Novasight Hybrid™ Hummingbird ConsoleTA-03-00052020-09-11
00628055603085Novasight Hybrid™ PIMTA-07-00012020-09-11
00628055603108Novasight Hybrid™ Catheter PIM BagSA-10-00292020-09-11
01628055603053Novasight Hybrid™ CatheterTA-06-00012020-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
00884450836316Performa®Merit Medical Systems, Inc.DQO2026-10-07
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884450787793Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884450788868Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25