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 introducer, catheter
510(k) Number K111092
Device Name ENGAGE/ENGAGE TR INTRODUCERS
Applicant
ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA,  MN  55345 -2126
Applicant Contact VENKATA DAMARAJU
Correspondent
ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA,  MN  55345 -2126
Correspondent Contact VENKATA DAMARAJU
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/19/2011
Decision Date 06/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
-
-