• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name catheter, percutaneous
510(k) Number K042850
Device Name CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)
Applicant
STEREOTAXIS, INC.
4041 forest park ave.
st. louis,  MO  63108
Applicant Contact gary rauvola
Correspondent
STEREOTAXIS, INC.
4041 forest park ave.
st. louis,  MO  63108
Correspodent Contact gary rauvola
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/15/2004
Decision Date 08/09/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-