K232469
- 510(k) number
- K232469
- Device name
- Rüsch Latex Gold Foley Catheter
- Applicant
- Teleflexmedical, Inc. NC · US
- Product code
- EZL — Catheter, Retention Type, Balloon
- Decision date
- 2024-08-01
- Date received
- 2023-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K232469.pdf
Official FDA record: K232469
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.