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510(k) K201404

Passio Pump Drainage System by Bearpac Medical — Product Code DWM

K201404 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 on November 20, 2020. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Bearpac Medical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2020
Date Received
May 28, 2020
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

Other clearances by Bearpac Medical

  • K230319 — Passio Pump Drainage System (November 24, 2023)
  • K190292 — Passio Pump Drainage System (July 25, 2019)

Other clearances for product code DWM

  • K212696 — Aspira Pleural Drainage System (March 3, 2023)
  • K210509 — Rocket Platinum Cured Cathter (September 9, 2021)
  • K190292 — Passio Pump Drainage System (July 25, 2019)
  • K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (August 17, 2017)
  • K160450 — Pleurx Pleural Catheter System (October 31, 2016)
  • K141965 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT (July 2, 2015)
  • K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PA (February 1, 2013)
  • K121849 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSE (October 18, 2012)
  • K112831 — PLEURX PLEURAL CATHETER SYSTEMS (February 16, 2012)
  • K110409 — ASPIRA PLEURAL DRAINAGE SYSTEM (May 11, 2011)

FDA data resources