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Conavi Medical Inc: FDA-registered device maker in Toronto Ontario, Canada, 3 510(k) clearances

Name: Conavi Medical Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Conavi Medical Inc is registered with the FDA (registration 3012198618) in Toronto Ontario, Canada. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 17, 2026. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012198618
Address: 293 Lesmill Road, Toronto Ontario, Canada, M3B 2V1
Owner or operator: Conavi Medical Inc. (10050995)
Roles: Manufacturer, Specification developer
First device listed: March 18, 2019
Registered through: 2026
Brand names listed: Conavi IVUS OCT Hybrid Catheter, Foresight ICE System, Novasight Hybrid System

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Diagnostic	DQO	2	Manufacturer	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Specification developer	accessdata.fda.gov
System, Imaging, Optical Coherence Tomography (Oct)	NQQ	2	Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 17, 2026	K252945	Novasight Hybrid System	OBJ	Substantially Equivalent	Conavi Medical, Inc.	accessdata.fda.gov
April 27, 2018	K172258	Novasight Hybrid System	OBJ	Substantially Equivalent	Conavi Medical, Inc.	accessdata.fda.gov
March 28, 2017	K162789	Foresight Intracardiac Echocardiology (ICE) System	DQO	Substantially Equivalent	Conavi Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 12, 2025	96444	Class I	Ongoing	Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter	Due to manufacturing issues there is a potential for the catheter sheath to detach.	accessdata.fda.gov

Compare with other makers

Updated April 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.