• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K133151
Device Name SARNS HIGH FLOW AORTIC ARCH CANNULA
Original Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball rd.
elkton,  MD  21921
Original Contact garry a courtney
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/17/2013
Decision Date 02/03/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-