|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
6f engage/engage tr introducer
|
ST. JUDE MEDICAL
|
K101883 |
09/07/2010
|
across transseptal access system, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
|
ST. JUDE MEDICAL
|
K070417 |
06/05/2007
|
agilis nxt steerable introducer, model g408322 and g408323
|
ST. JUDE MEDICAL
|
K083402 |
12/15/2008
|
agilis es steerable introducer
|
ST. JUDE MEDICAL
|
K103083 |
04/08/2011
|
agilis nxt steerable introducer
|
ST. JUDE MEDICAL
|
K061363 |
07/12/2006
|
agilis nxt steerable introducer
|
ST. JUDE MEDICAL
|
K083083 |
11/06/2008
|
agilis nxt steerable introducer
|
ST. JUDE MEDICAL
|
K110450 |
05/10/2011
|
agilis nxt steerable introducer, model g408324
|
ST. JUDE MEDICAL
|
K081645 |
12/09/2008
|
agilis steerable catheter introducer, model 408304
|
ST. JUDE MEDICAL, DAIG DIVISION, INC.
|
K042623 |
01/27/2005
|
agills pf delivery system
|
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
|
K111943 |
09/29/2011
|