|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
ultimum hemostasis introducer, model 4076xx
|
ST. JUDE MEDICAL, INC.
|
K001346 |
05/24/2000
|
fast-cath 18f hemostasis introducer, model 406xxx
|
ST. JUDE MEDICAL, INC.
|
K001367 |
05/31/2000
|
ultimum ev hemostasis introducer (14f), ultimum ev hemostasis introducer (16f), ultimum ev hemostasis introducer (18f),
|
ST. JUDE MEDICAL
|
K003729 |
01/03/2001
|
ultraflex ev hemostasis introducer
|
ST. JUDE MEDICAL
|
K012922 |
09/25/2001
|
seal-away cs introducer kit, models 407514, 407515
|
ST. JUDE MEDICAL
|
K013029 |
10/09/2001
|
modification to ultimum ev hemostasis introducer (22f)
|
ST. JUDE MEDICAL
|
K023447 |
10/31/2002
|
apeel cs catheter delivery system
|
ST. JUDE MEDICAL
|
K031906 |
07/18/2003
|
agilis steerable catheter introducer, model 408304
|
ST. JUDE MEDICAL, DAIG DIVISION, INC.
|
K042623 |
01/27/2005
|
apeel cs plus catheter delivery system, models 407579, 407580, 407581, 407582
|
ST. JUDE MEDICAL, DAIG DIVISION, INC.
|
K051096 |
05/17/2005
|
swartz braided transseptal guiding introducer
|
ST. JUDE MEDICAL
|
K052644 |
12/05/2005
|