VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter— 510(k) K200812
Substantially EquivalentPhilips Image Guided Therapy Corporation
FDA 510(k) clearance K200812 for VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter, Substantially Equivalent on 2020-09-02. Applicant: Philips Image Guided Therapy Corporation.
Clearance details
- Applicant
- Philips Image Guided Therapy Corporation
- Product code
- Code OBJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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.