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510(k) K230319

Passio Pump Drainage System by Bearpac Medical — Product Code PNG

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.

Other clearances by Bearpac Medical

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  • K190292 — Passio Pump Drainage System (July 25, 2019)

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  • K122422 — PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PE (October 24, 2012)
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