Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 | HDE | Classification | Standards
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 K043179
Device Name SELECT 3D ARTERIAL CANNULA
Applicant
MEDTRONIC PERFUSION SYSTEMS
7611 NORTHLAND DR.
MINNEAPOLIS,  MN  55038
Applicant Contact RONALD W BENNETT
Correspondent
MEDTRONIC PERFUSION SYSTEMS
7611 NORTHLAND DR.
MINNEAPOLIS,  MN  55038
Correspondent Contact RONALD W BENNETT
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/17/2004
Decision Date 02/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
-
-