OBJ

Catheter, Ultrasound, Intravascular

Product code
OBJ
Device name
Catheter, Ultrasound, Intravascular
Device class
Class 2
21 CFR
21 CFR 870.1200
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
14
Summaries archived here
14 (direct download)
510(k) clearances (all years, FDA)
79 (all years; only the last 3 years are listed here)

FDA classification definition

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (14)

Last three years. Most recent: 2026-07-24.

NumberDecision dateApplicantDevice nameSummary
K2618492026-07-24Luma Vision LimitedVERAFEYE Imaging Catheter (VF-VIC-002)PDF
K2529452026-04-17Conavi Medical, Inc.Novasight Hybrid SystemPDF
K2608162026-04-08Boston ScientificOptiCross Coronary Imaging Catheter (H749518110); Op…PDF
K2533992025-10-28Volcano Corporation (Dba Philips Image…Visions® PV .014P RX Digital IVUS Catheter ; Visions…PDF
K2509552025-10-22Yorlabs, Inc.XC11 ICE System, USAPDF
K2509132025-07-19Jiangsu Tingsn Technology Co., Ltd.TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound…PDF
K2512112025-05-23ABBOTT MEDICALViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocess…PDF
K2512312025-05-20ABBOTT MEDICALViewFlex™ X ICE Catheter, Sensor Enabled™PDF
K2511032025-05-09Philips Image Guided Therapy Corporati…VeriSight Intracardiac Echocardiography Catheter (VS…PDF
K2428932025-03-24Luma Vision LimitedVERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE…PDF
K2415402024-06-28Biosense Webster, Inc.NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultraso…PDF
K2400502024-06-12Biosense Webster, Inc.SOUNDSTAR™ CRYSTAL Ultrasound CatheterPDF
K2339482024-04-23Provisio Medical, Inc.Provisio™ SLT IVUS™ SystemPDF
K2332702023-10-28Siemens Medical Solutions USA, Inc.AcuNav Crystal Ultrasound CatheterPDF

14 summaries are archived here for direct download.

Official FDA classification page: OBJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).