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510(k) K201155

PleurX Peritoneal Catheter System by Care Fusion — Product Code PNG

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 21, 2020
Date Received
April 30, 2020
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.

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