Conavi Medical Inc

Toronto Ontario, CA

Conavi Medical Inc appears in FDA device records in Toronto Ontario, CA. FDA records list 3 510(k) clearances between 2017-03-28 and 2026-04-17, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Conavi Medical Inc between 2017 and 2026. The busiest year on record is 2017, with 1. The most recent is 2026, with 1.

Clearances by year, as a table

510(k) clearance decisions for Conavi Medical Inc, by decision year
Year	Clearances
2017	1
2018	1
2026	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K252945	Novasight Hybrid System	OBJ	Substantially Equivalent	2026-04-17
K172258	Novasight Hybrid System	OBJ	Substantially Equivalent	2018-04-27
K162789	Foresight Intracardiac Echocardiology (ICE) System	DQO	Substantially Equivalent	2017-03-28

Registered establishments

FDA registered establishments for Conavi Medical Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3012198618	3012198618	Conavi Medical Inc	293 Lesmill Road, Toronto Ontario M3B 2V1 CA	2026	DQO ITX IYO NQQ OBJ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1585-2025	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 is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.	Due to manufacturing issues there is a potential for the catheter sheath to detach.	Class I	2025-03-12	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain