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, administration, intravascular
510(k) Number K210430
Device Name Intravascular Extension Set
Applicant
Baxter Healthcare Corporation
25212 West Illinois Route 120
Round Lake,  IL  60073
Applicant Contact Meaghan Bonn
Correspondent
Baxter Healthcare Corporation
25212 West Illinois Route 120
Round Lake,  IL  60073
Correspondent Contact Meaghan Bonn
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/12/2021
Decision Date 06/18/2021
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
-
-