• 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 K860307
Device Name PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET
Original Applicant
TELEFLEX, INC.
tall pines park
jeffrey,  NH  03452
Original Contact gary bullard
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/28/1986
Decision Date 05/20/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-