|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
penumbra system, penumbra pump max
|
PENUMBRA, INC.
|
K160449 |
05/25/2016
|
penumbra system separator flex (026,032,041,054), models psf026, psf032, psf041, psf054
|
PENUMBRA, INC.
|
K100769 |
05/21/2010
|
penumbra system reperfusion catheter jet 7
|
Penumbra, Inc.
|
K173761 |
08/17/2018
|
penumbra system reperfusion catheter jet 7
|
Penumbra, Inc.
|
K190010 |
06/16/2019
|
penumbra system penumbra jet 7x
|
Penumbra, Inc.
|
K191946 |
02/27/2020
|
penumbra system max
|
PENUMBRA, INC.
|
K113163 |
11/23/2011
|
penumbra system ace 68 reperfusion catheter
|
Penumbra, Inc.
|
K161064 |
06/12/2016
|
penumbra system ace 68 reperfusion catheter
|
Penumbra, Inc.
|
K161640 |
07/12/2016
|
penumbra system ace 64 and ace 68 reperfusion catheters
|
PENUMBRA, INC.
|
K152541 |
01/13/2016
|
penumbra system ace
|
PENUMBRA, INC.
|
K142458 |
05/22/2015
|
|