Volcano Corporation (Dba Philips Image Guided Therapy Device

FDA Regulatory Profile

Volcano Corporation (Dba Philips Image Guided Therapy Device appears in FDA public data with 0 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 28, 2025.

Summary

Total Recalls
0
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterOctober 28, 2025