• 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 K060519
Device Name INTRODUCER ASSEMBLY WITH ROTATOR LOCK
Original Applicant
TELEFLEX MEDICAL
2345 waukegan road
suite 140
bannockburn,  IL  60015
Original Contact lori hays
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/27/2006
Decision Date 05/05/2006
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
-
-