Cardiovascular · 510(k) · 2026
Novasight Hybrid System
Conavi Medical, Inc.. Cleared by FDA on 17 April 2026 under submission K252945, product code OBJ (catheter, ultrasound, intravascular). What FDA's record says, in FDA's words.
Device record · K252945
- Device. Novasight Hybrid SystemDEVICE
- Company. Conavi Medical, Inc. (CA)COMPANY
- Decision. 17 April 2026, 510(k), substantially equivalent (traditional review); received 15 September 2025DECISION
- Panel. CardiovascularPANEL
- Product code. OBJ, Catheter, Ultrasound, IntravascularCODE
- Regulation. 21 CFR 870.1200, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K252945Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? Novasight Hybrid System Please provide your Indications for Use below. The Novasight Hybrid System is intended for intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. I Please select the types of uses (select one or both, as ZPrescription Use (Part 21 CFR 801 Subpart D) [ Over-The-Counter Use (21 CFR 801 Subpart C)applicable). Novasight Hybrid System 510(k) Notification Conavi Medical Inc. 510(k) Summary 510( k) Number: K252945 Applicant Information: Date Prepared: April 9, 2026 Name: Conavi Medical Inc. Address: 293 Lesmill Road North York, ON, Canada M3B 2V1 Contact Person: Sophia Farcas [email protected] Mobile Number: +1 (647) 970-7959 D evice Information: Trade/Proprietary Name: Novasight Hybrid System Common Name: Novasight Hybrid System
The product code's definition, from FDA's classification record. For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionstriage or notification
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 8,056 reports filed against devices carrying product code OBJ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · OptiCross? 6 HD · BOSTON SCIENTIFIC CORPORATION · report 2124215-2026-51928
It was reported that catheter issue occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending (LAD) artery. The left main artery was not calcified. An OptiCross 6 HD imaging catheter was advanced into the left main artery. Resistance was encountered while advancing toward the LAD, possibly due to the left main angulation and the catheter began to separate from the wire. When the device was removed, it was noted that the […]
30 September 2026 · Other · AcuNav Crystal Ultrasound Catheter · report MW6003168
Upon repositioning of intracardiac echocardiography (ICE) catheter in the left femoral vein 10-french access sheath, sheath became dislodged from left femoral vein while ICE catheter remained in groin unable to be removed. Incision made in groin and ICE catheter removed from groin; figure-8 suture to close incision.
30 September 2026 · Malfunction · OptiCross HD · BOSTON SCIENTIFIC CORPORATION · report 2124215-2026-51940
It was reported that a catheter issue occurred.The 86% stenosed target lesion was located in the moderately calcified left anterior descending artery. An OptiCross HD imaging catheter was advanced for intravascular ultrasound (IVUS) examination of the target lesion. During the procedure, the catheter fractured and became entangled. The procedure was completed using another device of the same model. There were no patient complications, and the patient remained stable.
30 September 2026 · Malfunction · OptiCross? 6 HD · BOSTON SCIENTIFIC CORPORATION · report 2124215-2026-52021
30 September 2026 · Malfunction · OptiCross HD · BOSTON SCIENTIFIC CORPORATION · report 2124215-2026-52020
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OBJ, in Cardiovascular, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.