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 Set, I.V. Fluid Transfer
510(k) Number K243404
Device Name HyHub™ and HyHub™ Duo Vial Access Devices
Applicant
Takeda Pharmaceuticals
500 Kendall St.
Cambridge,  MA  02142
Applicant Contact Louwanna Wilson
Correspondent
Takeda Pharmaceuticals
200 Shire Way
Lexington,  MA  02421
Correspondent Contact Avanti Sawant
Regulation Number880.5440
Classification Product Code
LHI  
Date Received11/01/2024
Decision Date 07/18/2025
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
-
-