Conavi Medical Inc

FDA Device Registration & Listing · Toronto Ontario, CA · Registration 3012198618

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012198618
FEI Number
3012198618
Entity Name
Conavi Medical Inc
City/State/Country
Toronto Ontario, CA
Establishment Address
293 Lesmill Road, Toronto Ontario M3B 2V1, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Conavi Medical Inc. (Owner Number: 10050995)
Owner / Operator Contact Address
293 Lesmill Road, Toronto, CA-ON M3B 2V1, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Novasight Hybrid System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2019-03-18
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2019-03-18
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-03-18

Official Correspondent

David Zhang

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Conavi Medical Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K251211 ABBOTT MEDICAL ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ 2025-05-23
K251231 ABBOTT MEDICAL ViewFlex™ X ICE Catheter, Sensor Enabled™ 2025-05-20
K183320 St. Jude Medical (Now Abbott Medical) Ilumien Optis, Optis Integrated, Optis Mobile 2019-04-02
K253459 ABBOTT MEDICAL OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) 2026-04-24
K210458 ABBOTT MEDICAL OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System 2021-06-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2016 Biosense Webster, Inc. 2
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012198618. Last updated year: 2026. Please use registration number 3012198618 when referencing this establishment in official correspondence.
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