FDA.reportPublic FDA data

Novasight Hybrid™ Catheter

Primary DI
00628055603115
Brand
Novasight Hybrid™ Catheter
Company
Conavi Medical Inc
Model
TA-06-0001
Device description
Imaging catheter consists of Novasight Hybrid Catheter, Accessory Pack and PIM Bag.
Published
2023-04-17
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
05628055603110PackageGS15In Commercial Distribution
10628055603112PackageGS110In Commercial Distribution
00628055603115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
05628055603110056280556031105628055603110
1062805560311210628055603112
00628055603115006280556031156280556031150628055603115

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
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
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
00199874783659LIA ConsoleLEADOPTIK INC.NQQ2026-06-01
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08800290041705miniER7SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041941CMV1-10SAMSUNG MEDISON CO., LTD.IYO2025-12-05