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510(k) K190292

Passio Pump Drainage System by Bearpac Medical — Product Code DWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2019
Date Received
February 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Patient Care
Device Class
Class II
Regulation Number
870.5050
Review Panel
AN
Submission Type

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  • K121849 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSE (October 18, 2012)
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  • K110409 — ASPIRA PLEURAL DRAINAGE SYSTEM (May 11, 2011)