• 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 introducer, catheter
510(k) Number K960406
Device Name BRAUN HEMOSTASIS INTRODUCERS
Original Applicant
B. BRAUN MEDICAL, INC.
1300 hwy 55
minneapolis,  MN  55411 3813
Original Contact barbara atzenhoefer
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/29/1996
Decision Date 04/12/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-