K251103

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)

510(k) number
K251103
Device name
VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)
Applicant
Philips Image Guided Therapy Corporation CA · US
Product code
OBJ — Catheter, Ultrasound, Intravascular
Decision date
2025-05-09
Date received
2025-04-11
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K251103.pdf

Official FDA record: K251103
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.