DeviceClearance

VeriSight Intracardiac Echocardiography Catheter (VSICE2D) +1 more— 510(k) K251103

Substantially Equivalent

Philips Image Guided Therapy Corporation

FDA 510(k) clearance K251103 for VeriSight Intracardiac Echocardiography Catheter (VSICE2D) +1 more, Substantially Equivalent on 2025-05-09. Applicant: Philips Image Guided Therapy Corporation. Device class: 2.

Clearance details

Device name as filed
VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)
Applicant
Philips Image Guided Therapy Corporation
Product code
Code OBJ
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code OBJ

view all

More clearances from Philips Image Guided Therapy Corporation

view all

Adverse events under product code OBJ

product code OBJ
Death
38
Injury
634
Malfunction
3,453
Total
4,125

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

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