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 Vacuum Syringe
510(k) Number K233069
Device Name Removal System Large Bore 60 cc Syringe
Applicant
Inari Medical, Inc.
6001 Oak Canyon
Suite 100
Irvine,  CA  92618
Applicant Contact Kaitlyn Weinkauf
Correspondent
Inari Medical, Inc.
6001 Oak Canyon
Suite 100
Irvine,  CA  92618
Correspondent Contact Kaitlyn Weinkauf
Regulation Number880.5860
Classification Product Code
PUR  
Date Received09/26/2023
Decision Date 03/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-