• 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, percutaneous
510(k) Number K953515
Device Name SCIMED TRIGUIDE GUIDE CATHETERS
Original Applicant
SCIMED LIFE SYSTEMS, INC.
one scimed place
maple grove,  MN  55311 1566
Original Contact diane m lowe
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/26/1995
Decision Date 09/19/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-