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FDA 510(k) Applications Submitted by GREG JOHNSON
FDA 510(k) Number
Submission Date
Device Name
Applicant
K160257
02/01/2016
PROTEK Duo 31 Fr. Veno-Venous Cannula Set
CARDIAC ASSIST, INC.
K140999
04/18/2014
TANDEMHEART VENO-VENOUS CANNULA
CARDIACASSIST INC.
K181150
05/01/2018
ProtekDuo Mini Veno-Venous Cannula Set
CardiacAssist Inc
K061411
05/22/2006
TORBOT VASCULAR COMPRESSION GARMENTS
TORBUT GROUP, INC.
K081815
06/26/2008
VOCALIS GEL
CYTOPHIL INC
K081816
06/26/2008
VOCALIS AND VOCALIS SM
CYTOPHIL INC
K162181
08/04/2016
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
CARDIACASSIST INC.
K162214
08/08/2016
Protek Solo 24 Fr Venous Cannula Set
CARDIAC ASSIST, INC.
K072219
08/10/2007
CYTOPHIL TISSUE MARKER
CYTOPHIL INC
K133236
10/21/2013
TANDEMHEART FEMORAL VENOUS CANNULA SET
CARDIAC ASSIST, INC.
K133293
10/25/2013
15 FR. TANDEMHEART ARTERIAL CANNULA
CARDIACASSIST INC.
K153295
11/13/2015
TandemLung Oxygenator
CARDIAC ASSIST, INC.
K183623
12/26/2018
LifeSPARC Pump, LifeSPARC Controller
CardiacAssist Inc
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