K241278
- 510(k) number
- K241278
- Device name
- ASEPT® Glide Peritoneal Drainage System
- Applicant
- Pfm Medical, Inc. CA · US
- Product code
- PNG — Peritoneal, Drainage Catheter For Refractory Ascites
- Decision date
- 2025-01-14
- Date received
- 2024-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241278.pdf
Official FDA record: K241278
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.