510(k) Report

FDA applicant

Conavi Medical, Inc.

Toronto, CA3 decisions2017–20261 recall

FDA records 3 decisions for Conavi Medical, Inc. (Toronto, CA) from 2017 to 2026: 3 510(k) clearances. Most are in product codes OBJ (Catheter, Ultrasound, Intravascular) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 6 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Conavi Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2017: 12018: 12026 (partial year): 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1, 1 Class I
2017high 1 (2025) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Conavi Medical, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Conavi Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OBJCatheter, Ultrasound, Intravascular2decisions
  • DQOCatheter, Intravascular, Diagnostic1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K172258Novasight Hybrid SystemConavi Medical, Inc. · 20181cites it

What has FDA decided for it lately?

  • K252945Novasight Hybrid SystemConavi Medical, Inc. · 2026
  • K172258Novasight Hybrid SystemConavi Medical, Inc. · 20181 Class I recall
  • K162789Foresight Intracardiac Echocardiology (ICE) SystemConavi Medical, Inc. · 2017

All 3 as Conavi Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K172258Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter…Mar 12, 2025Class I