K251358
- 510(k) number
- K251358
- Device name
- Bridge Plus Occlusion Balloon (590-002)
- Applicant
- Philips Image Guided Therapy Devices CO · US
- Product code
- MJN — Catheter, Intravascular Occluding, Temporary
- Decision date
- 2025-06-24
- Date received
- 2025-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251358.pdf
Official FDA record: K251358
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.