FDA-Device2025-04-30Class I
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-re
Conavi Medical Inc.
Hazard
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Sold states
US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China
Affected count
685
Manufactured in
293 Lesmill Rd, N/A, Toronto, N/A, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1585-2025Don't want to check this manually?
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