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 Ring, Annuloplasty
510(k) Number K014037
Device Name SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
Applicant
St. Jude Medical, Inc.
One Lillehei Plaza
St. Paul,  MN  55117
Applicant Contact WILLIAM MCKELVEY
Correspondent
St. Jude Medical, Inc.
One Lillehei Plaza
St. Paul,  MN  55117
Correspondent Contact WILLIAM MCKELVEY
Regulation Number870.3800
Classification Product Code
KRH  
Date Received12/07/2001
Decision Date 01/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-