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510(k) K231664

IRRAflow Active Fluid Exchange System (AFES) by Irras USA, Inc. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2023
Date Received
June 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Irras USA, Inc.

  • K222471 — IRRAflow Active Fluid Exchange System (AFES) (December 8, 2022)
  • K200807 — IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (April 29, 2020)
  • K192289 — IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (November 15, 2019)

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