|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
penumbra system
|
PENUMBRA, INC.
|
K072718 |
12/28/2007
|
penumbra system (pennumbra reperfusion catheter 054), model psc054; (penumbra separator 054), model pss054
|
PENUMBRA, INC.
|
K090752 |
09/21/2009
|
penumbra system separator flex (026,032,041,054), models psf026, psf032, psf041, psf054
|
PENUMBRA, INC.
|
K100769 |
05/21/2010
|
penumbra system max
|
PENUMBRA, INC.
|
K113163 |
11/23/2011
|
penumbra system / penumbra system max
|
PENUMBRA, INC.
|
K133317 |
05/13/2014
|
penumbra system ace
|
PENUMBRA, INC.
|
K142458 |
05/22/2015
|
penumbra system 110 aspiration tubing
|
Penumbra, Inc.
|
K151623 |
08/06/2015
|
penumbra system ace 64 and ace 68 reperfusion catheters
|
PENUMBRA, INC.
|
K152541 |
01/13/2016
|
penumbra 3d revascularization device
|
Penumbra, Inc.
|
K162901 |
04/20/2017
|
penumbra system ace 68 reperfusion catheter
|
Penumbra, Inc.
|
K161064 |
06/12/2016
|
|