• 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 catheter, intravascular, diagnostic
510(k) Number K113335
Device Name HEARTRAIL III GUIDING CATHETER
Original Applicant
TERUMO CORPORATION
44-1, 2-chome hatagaya
shibuya-ku tokyo,  JA 151-0072
Original Contact mark unterreiner
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/14/2011
Decision Date 07/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-