|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
8fr turbo - tandem system
|
SPECTRANETICS CORP.
|
K112032 |
10/17/2011
|
turbo-tandem system model 472-110
|
SPECTRANETICS CORP.
|
K094036 |
01/25/2010
|
spectranetics quick cross extreme support catheters
|
SPECTRANETICS CORP.
|
K092396 |
09/04/2009
|
spectranetics turbo-tandem system
|
SPECTRANETICS CORP.
|
K091299 |
07/01/2009
|
cross-pilot turbo elite support catheter
|
SPECTRANETICS CORP.
|
K090913 |
05/04/2009
|
spectranetics cross-pilot turbo elite support catheter
|
SPECTRANETICS CORP.
|
K082559 |
12/11/2008
|
spectranetics quick-cross extreme support catheters
|
SPECTRANETICS CORP.
|
K082561 |
12/10/2008
|
spectranetics quick-cross support2 catheters, models 518-065 and 518-066
|
SPECTRANETICS CORP.
|
K072750 |
12/04/2007
|
spectranetics quick cross catheters, models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038
|
SPECTRANETICS CORP.
|
K033678 |
02/23/2004
|
spectranetics 0.035 support catheter, model 518-028
|
SPECTRANETICS CORP.
|
K022138 |
09/23/2002
|