K230319
- 510(k) number
- K230319
- Device name
- Passio Pump Drainage System
- Applicant
- Bearpac Medical NH · US
- Product code
- PNG — Peritoneal, Drainage Catheter For Refractory Ascites
- Decision date
- 2023-11-24
- Date received
- 2023-02-06
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K230319
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.