Novasight Hybrid System— 510(k) K172258

Name: FDA 510(k) clearance K172258
Creator: U.S. Food and Drug Administration
Published: 2018-04-27

Substantially Equivalent

Conavi Medical, Inc.

FDA 510(k) clearance K172258 for Novasight Hybrid System, Substantially Equivalent on 2018-04-27. Applicant: Conavi Medical, Inc.. Device class: 2.

Clearance details

Applicant: Conavi Medical, Inc.
Product code: Code OBJ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2017-07-26
Decision date: 2018-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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K261696 — ACUNAV Luxera 4D ICE Catheter2026-09-10
K261849 — VERAFEYE Imaging Catheter (VF-VIC-002)2026-07-24
K252945 — Novasight Hybrid System2026-04-17
K260816 — OptiCross Coronary Imaging Catheter (H749518110) +7 more2026-04-08
K253399 — Visions® PV .014P RX Digital IVUS Catheter; Visions® PV .018 Digital IVUS Catheter2025-10-28

More clearances from Conavi Medical, Inc.

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K162789 — Foresight Intracardiac Echocardiology (ICE) System2017-03-28

Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K172258

K-number listed on FDA's recall record

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.Class I·Ongoing·Conavi Medical Inc.·20250312

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172258.

Data sourced from openFDA. This site is unofficial and independent of the FDA.