• 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, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K941916
Device Name QUEST CORONARY SINUS PERFUSION CANNULA -FRCC
Original Applicant
QUEST MEDICAL, INC.
one allentown pkwy.
allen,  TX  75002
Original Contact drew johnson
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/19/1994
Decision Date 04/06/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-