• 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 K961745
Device Name BRAUN PERCUTANEOUS INTRODUCER SET
Original Applicant
B. BRAUN MEDICAL, INC.
824 twelfth ave.
bethlehem,  PA  18018
Original Contact mark s alsberge
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/06/1996
Decision Date 09/17/1996
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
-
-