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510(k) K160437

PleurX Peritoneal Catheter System by Care Fusion — Product Code PNG

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
November 3, 2016
Date Received
February 17, 2016
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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