|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
terumo radifocus introducer kit
|
TERUMO MEDICAL CORP.
|
K863139 |
10/10/1986
|
renal guiding sheath
|
TERUMO MEDICAL CORP.
|
K012854 |
11/21/2001
|
radifocus introducer ii kit
|
TERUMO MEDICAL CORP.
|
K954234 |
11/27/1995
|
pinnacle roii introducer sheath
|
TERUMO MEDICAL CORP.
|
K082847 |
10/29/2008
|
pinnacle r/o or redifocus introducer r/o (comprised of a sheath & dilator)
|
TERUMO MEDICAL CORP.
|
K984260 |
01/26/1999
|
pinnacle r/o ii or radifocus introducer ii
|
TERUMO MEDICAL CORP.
|
K003424 |
11/21/2000
|
pinnacle precision access system
|
TERUMO MEDICAL CORP.
|
K111606 |
10/03/2011
|
pinnacle destination peripheral guiding sheath
|
TERUMO MEDICAL CORP.
|
K051601 |
08/04/2005
|
pinnacle destination peripheral guiding sheath
|
TERUMO MEDICAL CORP.
|
K081046 |
05/21/2008
|
pinnacle destination peripheral guiding sheath
|
TERUMO MEDICAL CORP.
|
K091329 |
05/29/2009
|