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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 sensor, pressure, aneurysm, implantable
De Novo Number DEN050006
510(K) Number K050939
Device Name CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
Requester
cardiomems, inc.
75 fifth st., nw
suite 440
atlanta,  GA  30308
Contact carol vierling
Regulation Number870.2855
Classification Product Code
NQH  
Date Received08/09/2005
Decision Date 10/28/2005
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
-
-