Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name shunt, central nervous system and components
510(k) Number K200807
Device Name IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
Applicant
IRRAS USA Inc.
11975 El Camino Real
San Diego,  CA  92130
Applicant Contact Niloufa Insanally
Correspondent
IRRAS USA Inc.
11975 El Camino Real
San Diego,  CA  92130
Correspondent Contact Niloufa Insanally
Regulation Number882.5550
Classification Product Code
JXG  
Subsequent Product Code
GWM  
Date Received03/27/2020
Decision Date 04/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-