FDA.reportPublic FDA data

Novasight Hybrid™ Catheter Accessories Package

Primary DI
00628055603061
Brand
Novasight Hybrid™ Catheter Accessories Package
Company
Conavi Medical Inc
Model
SA-10-0022
Device description
Imaging catheter accessories
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
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
NQQSystem, Imaging, Optical Coherence Tomography (Oct)
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172258000Novasight Hybrid SystemConavi Medical, Inc.2018-04-27OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055603061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055603061006280556030616280556030610628055603061

GMDN Terms#

Term, Definition table
TermDefinition
Coronary optical coherence tomography system catheterA sterile flexible tube with an extremely fine working end that houses an optical fibre and imaging lens intended to be transcutaneously introduced into the coronary vasculature to perform coronary optical coherence tomography (OCT). The proximal end of the device connects to a coronary OCT console for the transmission of high-resolution images (e.g., 5 to 40 micron) of the coronary intravasculature. It is typically made of stainless steel, plastic, and optical materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
200125243
Device count
1
Lot or batch
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
00628055603016Foresight ICE™ CatheterTA-01-00012020-09-11
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
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
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00845225013011ICE PIMPhilips Image Guided Therapy CorporationOBJ2026-07-30
10801902219333ARROWTELEFLEX INCORPORATEDOBJ2026-07-30
10801902194654ARROWTELEFLEX INCORPORATEDOBJ2026-07-29
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
00198953113493LOGIQGE Ultrasound Korea Ltd.IYO2026-01-21
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00198953042731LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00198953042755LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042762LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05