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FDA 510(k) Applications Submitted by Debra Kridner
FDA 510(k) Number
Submission Date
Device Name
Applicant
K000430
02/09/2000
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
MEDTRONIC VASCULAR
K960755
02/23/1996
CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
K180640
03/12/2018
SmartClip Soft Tissue Marker
Elucent Medical, Inc.
K210836
03/22/2021
InstruSafe Instrument Protection System
Summitt Medical LLC
K961836
05/13/1996
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
MEDTRONIC VASCULAR
K962641
07/05/1996
MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER
MEDTRONIC VASCULAR
K222404
08/09/2022
Evo« sEEG System
NeuroOne Medical Technologies Corp.
K992910
08/30/1999
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)
MEDTRONIC VASCULAR
K973475
09/12/1997
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
MEDTRONIC VASCULAR
K192764
09/30/2019
NeuroOne Cortical Electrode
NeuroOne, Inc.
K183400
12/07/2018
EnVisio Navigation Sytem
Elucent Medical, Inc
K955046
11/03/1995
SOFT VENOUS RESERVOIR
GISH BIOMEDICAL, INC.
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