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 Filter, Intravascular, Cardiovascular
510(k) Number K112119
Device Name CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH
Applicant
William Cook Europe Aps
One Geddes Way
West Lafayette,  IN  47906
Applicant Contact Jennifer Brown
Correspondent
William Cook Europe Aps
One Geddes Way
West Lafayette,  IN  47906
Correspondent Contact Jennifer Brown
Regulation Number870.3375
Classification Product Code
DTK  
Date Received07/25/2011
Decision Date 03/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-