• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name catheter, intravascular, diagnostic
510(k) Number K000956
Device Name MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
Original Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove,  MN  55311
Original Contact melanie raska
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/24/2000
Decision Date 04/21/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-