K243795
- 510(k) number
- K243795
- Device name
- pREBOA-PRO Catheter
- Applicant
- Prytime Medical Devices, Inc. TX · US
- Product code
- MJN — Catheter, Intravascular Occluding, Temporary
- Decision date
- 2025-09-05
- Date received
- 2024-12-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K243795.pdf
Official FDA record: K243795
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.