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510(k) K153434

Pall-Aquasafe Water Filter by Pall International Sarl — Product Code NHV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2016
Date Received
November 27, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Water Purification, General Medical Use
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.

Other clearances by Pall International Sarl

  • K163609 — Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Fau (June 1, 2017)

Other clearances for product code NHV

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  • K191563 — FILTRAY 2G Disposable Water Filters (October 25, 2019)
  • K182164 — Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Eco (March 29, 2019)
  • K173164 — Ecolab POU Water Filter (June 29, 2018)
  • K163609 — Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Fau (June 1, 2017)
  • K161467 — HydraGuard 10 UltraFilter (December 22, 2016)
  • K153784 — NOSOGARD FILTERS (October 21, 2016)
  • K153084 — Nephros S100 (April 8, 2016)
  • K141731 — NEPHROS DSU-H, NEPHROS SSU-H (October 24, 2014)
  • K012716 — MAINSTREAM WATER PURIFICATION DEVICE (May 7, 2002)