K240514
- 510(k) number
- K240514
- Device name
- AMT Low-Profile Suprapubic Catheter & Drainage Set
- Applicant
- Applied Medical Technology, Inc. OH · US
- Product code
- KOB — Catheter, Suprapubic (And Accessories)
- Decision date
- 2024-11-01
- Date received
- 2024-02-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240514.pdf
Official FDA record: K240514
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.