• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K031361
Device Name CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
Original Applicant
DELTEC, INC.
1265 grey fox rd.
st. paul,  MN  55112
Original Contact lisa stone
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/08/2003
Decision Date 05/23/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-