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510(k) K200807

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit by Irras USA, Inc. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2020
Date Received
March 27, 2020
Clearance Type
Special
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.

  • K231664 — IRRAflow Active Fluid Exchange System (AFES) (October 19, 2023)
  • K222471 — IRRAflow Active Fluid Exchange System (AFES) (December 8, 2022)
  • K192289 — IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (November 15, 2019)

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