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510(k) K081043

LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT by Nxstage Medical, Inc. — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2008
Date Received
April 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K141752 — NXSTAGE SYSTEM ONE (December 19, 2014)

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  • K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (November 5, 2015)
  • K141997 — CRIT-LINE IV SYSTEM (April 1, 2015)
  • K141281 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (August 14, 2014)