510(k) K230319
K230319 is an FDA 510(k) premarket notification submitted by Bearpac Medical for the device "Passio Pump Drainage System". The FDA issued a decision of Substantially Equivalent (kit) on November 24, 2023. The device falls under product code PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Bearpac Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- November 24, 2023
- Date Received
- February 6, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type
For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.